Clinical Trial Results:
A multi-center, double-blind, double-dummy, randomized, controlled, parallel-group study to assess efficacy and safety of SH T00658ID compared to SH D593B in the treatment of primary dysmenorrhea
Summary
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EudraCT number |
2008-005625-11 |
Trial protocol |
DE IT |
Global end of trial date |
18 Nov 2010
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Results information
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Results version number |
v1 |
This version publication date |
12 Jul 2016
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First version publication date |
26 Jun 2015
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Other versions |
v2 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BAY86-5027/91781
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00909857 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Bayer HealthCare AG
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Sponsor organisation address |
Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
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Public contact |
Therapeutic Area Head, Bayer HealthCare AG, clinical-trials-contact@bayerhealthcare.com
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Scientific contact |
Therapeutic Area Head, Bayer HealthCare AG, clinical-trials-contact@bayerhealthcare.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Jan 2011
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Nov 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of the study was to show superiority of SH T00658ID over SH D593B with respect to the number of days with dysmenorrheic pain (defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode) in a defined period, i.e. comparison between two treatment cycles and two baseline cycles.
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Only after the subject voluntarily signed the informed consent form was he/she able to enter the study. If the subject was not capable of providing a signature, an oral statement of consent could have been given in the presence of a witness. Each subject was assured of the right to withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Apr 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 96
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Country: Number of subjects enrolled |
Italy: 59
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Country: Number of subjects enrolled |
Chile: 53
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Country: Number of subjects enrolled |
Canada: 11
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Country: Number of subjects enrolled |
Philippines: 97
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Country: Number of subjects enrolled |
Germany: 148
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Worldwide total number of subjects |
464
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EEA total number of subjects |
207
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
24
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Adults (18-64 years) |
440
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects aged 14 to 50 years with a need for oral contraception suffering from primary dysmenorrhea were recruited at specialized study sites. | ||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Out of 771 subjects screened, 264 failed screening, mostly due to not meeting in-/exclusion criteria (155), withdrawal of consent (49), loss to follow-up (36) or pregnancy (10). Thus, 507 subjects were randomized (253 to Estradiol valerate/Dienogest and 254 to Ethinyl estradiol/Levonorgestrel), out of which 464 subjects received treatment. | ||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||
Roles blinded |
Carer, Subject, Investigator | ||||||||||||||||||||||||||||||||||||
Blinding implementation details |
For blinding purposes, a double-dummy design was used. The investigational and reference product were packed for a double-dummy design in one wallet with two blisters of 28 tablets each.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | ||||||||||||||||||||||||||||||||||||
Arm description |
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. | ||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo Match to SH T00658ID
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
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Investigational medicinal product name |
Estradiol Valerate, Dienogest (SH T00658ID)
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Investigational medicinal product code |
BAY86-5027
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Other name |
Natazia, Qlaira
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
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Arm title
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Ethinyl Estradiol, Levonorgestrel (Miranova) | ||||||||||||||||||||||||||||||||||||
Arm description |
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles. | ||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo Match to SH D593B
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles.
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Investigational medicinal product name |
Ethinyl Estradiol, Levonorgestrel (SH D593B)
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Investigational medicinal product code |
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Other name |
Miranova
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles.
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Period 2
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Period 2 title |
Baseline period
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Is this the baseline period? |
Yes [1] | ||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||
Roles blinded |
Carer, Subject, Investigator | ||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | ||||||||||||||||||||||||||||||||||||
Arm description |
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period. | ||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Estradiol Valerate, Dienogest (SH T00658ID)
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Investigational medicinal product code |
BAY86-5027
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Other name |
Natazia, Qlaira
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
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Investigational medicinal product name |
Placebo Match to SH T00658ID
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
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Arm title
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Ethinyl Estradiol, Levonorgestrel (Miranova) | ||||||||||||||||||||||||||||||||||||
Arm description |
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period. | ||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Ethinyl Estradiol, Levonorgestrel (SH D593B)
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Investigational medicinal product code |
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Other name |
Miranova
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles.
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Investigational medicinal product name |
Placebo Match to SH D593B
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles.
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Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: In overall trial, all subjects who were randomized were included and the baseline characteristics were provided only for subjects who were treated. Hence, the baseline period of treated subjects was created to publish the baseline characteristics data. |
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Baseline characteristics reporting groups
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Reporting group title |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
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Reporting group description |
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period. | ||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ethinyl Estradiol, Levonorgestrel (Miranova)
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Reporting group description |
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period. | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
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Reporting group description |
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. | ||
Reporting group title |
Ethinyl Estradiol, Levonorgestrel (Miranova)
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Reporting group description |
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles. | ||
Reporting group title |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
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Reporting group description |
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period. | ||
Reporting group title |
Ethinyl Estradiol, Levonorgestrel (Miranova)
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Reporting group description |
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period. | ||
Subject analysis set title |
Full analysis set (FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available were included in the FAS.
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End point title |
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain | ||||||||||||
End point description |
Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
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End point type |
Primary
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End point timeframe |
Baseline period (2 baseline cycles, usually 56 days) versus (vs) treatment period (on-treatment cycles 2 and 3, usually 56 days)
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Notes [1] - FAS [2] - FAS |
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Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
An individual absolute change in days with dysmenorrheic pain from pretreatment was evaluated as number of days with dysmenorrheic pain during the treatment evaluation period minus number of days with dysmenorrheic pain during the pretreatment evaluation period.
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Comparison groups |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) v Ethinyl Estradiol, Levonorgestrel (Miranova)
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Number of subjects included in analysis |
444
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.3358 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Difference of mean changes from baseline | ||||||||||||
Point estimate |
-0.404
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-1.227 | ||||||||||||
upper limit |
0.4196 |
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End point title |
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain | ||||||||||||
End point description |
Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference minimum -168 (best), maximum 168 (worst).
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End point type |
Secondary
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End point timeframe |
Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
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Notes [3] - FAS [4] - FAS |
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No statistical analyses for this end point |
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End point title |
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding | ||||||||||||
End point description |
Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
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End point type |
Secondary
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End point timeframe |
Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
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Notes [5] - FAS [6] - FAS |
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No statistical analyses for this end point |
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End point title |
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding | ||||||||||||
End point description |
Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).
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End point type |
Secondary
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End point timeframe |
Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
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Notes [7] - FAS [8] - FAS |
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No statistical analyses for this end point |
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End point title |
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode) | ||||||||||||
End point description |
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
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End point type |
Secondary
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End point timeframe |
Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
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Notes [9] - FAS [10] - FAS |
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No statistical analyses for this end point |
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End point title |
Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used) | ||||||||||||
End point description |
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
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End point type |
Secondary
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End point timeframe |
Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
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Notes [11] - FAS [12] - FAS |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before) | ||||||||||||||||||||||||
End point description |
Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
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End point type |
Secondary
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End point timeframe |
Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
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Notes [13] - FAS [14] - FAS |
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No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Subjects With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used) | ||||||||||||||||||||||||
End point description |
Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Notes [15] - FAS [16] - FAS |
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Satisfied With Study Treatment | ||||||||||||||||||||||||||||||
End point description |
Subjects were asked to express the degree of their satisfaction with study treatment.
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
From cycle 1 to cycle 3 (28 days per cycle)
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
Notes [17] - FAS [18] - FAS |
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Days With Bleeding or Spotting | ||||||||||||
End point description |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From day 1 to day 90
|
||||||||||||
|
|||||||||||||
Notes [19] - FAS [20] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Episodes With Bleeding or Spotting | ||||||||||||
End point description |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From day 1 to day 90
|
||||||||||||
|
|||||||||||||
Notes [21] - FAS [22] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Mean Length of Bleeding or Spotting Episodes | ||||||||||||
End point description |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From day 1 to day 90
|
||||||||||||
|
|||||||||||||
Notes [23] - FAS [24] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Maximum Length of Bleeding or Spotting Episodes | ||||||||||||
End point description |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From day 1 to day 90
|
||||||||||||
|
|||||||||||||
Notes [25] - FAS [26] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode | ||||||||||||
End point description |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From day 1 to day 90
|
||||||||||||
|
|||||||||||||
Notes [27] - FAS [28] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Days With Spotting-only | ||||||||||||
End point description |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From day 1 to day 90
|
||||||||||||
|
|||||||||||||
Notes [29] - FAS [30] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Episodes With Spotting-only | ||||||||||||
End point description |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From day 1 to day 90
|
||||||||||||
|
|||||||||||||
Notes [31] - FAS [32] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Mean Length of Spotting Only Episodes | ||||||||||||
End point description |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From day 1 to day 90
|
||||||||||||
|
|||||||||||||
Notes [33] - FAS [34] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Maximum Length of Spotting Only Episodes | ||||||||||||
End point description |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From day 1 to day 90
|
||||||||||||
|
|||||||||||||
Notes [35] - FAS [36] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Difference in Duration Between Longest and Shortest Spotting Only Episode | ||||||||||||
End point description |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From day 1 to day 90
|
||||||||||||
|
|||||||||||||
Notes [37] - FAS [38] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects With Withdrawal Bleeding at Cycle 1 | ||||||||||||
End point description |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 1 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [39] - FAS [40] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects With Withdrawal Bleeding at Cycle 3 | ||||||||||||
End point description |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 3 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [41] - FAS [42] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Length of Withdrawal Bleeding Episodes at Cycle 1 | ||||||||||||
End point description |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 1 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [43] - FAS [44] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Length of Withdrawal Bleeding Episodes at Cycle 3 | ||||||||||||
End point description |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 3 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [45] - FAS [46] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 | ||||||||||||
End point description |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 1 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [47] - FAS [48] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 | ||||||||||||
End point description |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 3 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [49] - FAS [50] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Onset of Withdrawal Bleeding Episodes at Cycle 1 | ||||||||||||
End point description |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 1 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [51] - FAS [52] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Onset of Withdrawal Bleeding Episodes at Cycle 3 | ||||||||||||
End point description |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 3 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [53] - FAS [54] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects With Intracyclic Bleeding at Cycle 1 | ||||||||||||
End point description |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 1 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [55] - FAS [56] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects With Intracyclic Bleeding at Cycle 3 | ||||||||||||
End point description |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 3 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [57] - FAS [58] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Intracyclic Bleeding Episodes at Cycle 1 | ||||||||||||
End point description |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 1 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [59] - FAS [60] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Intracyclic Bleeding Episodes at Cycle 3 | ||||||||||||
End point description |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 3 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [61] - FAS [62] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Maximum Length of Intracyclic Bleeding Episodes at Cycle 1 | ||||||||||||
End point description |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 1 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [63] - FAS [64] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Maximum Length of Intracyclic Bleeding Episodes at Cycle 3 | ||||||||||||
End point description |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 3 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [65] - FAS [66] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Intracyclic Bleeding Days at Cycle 1 | ||||||||||||
End point description |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 1 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [67] - FAS [68] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of Intracyclic Bleeding Days at Cycle 3 | ||||||||||||
End point description |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At cycle 3 (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [69] - FAS [70] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Subjects With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 | ||||||||||||||||||||||||
End point description |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At cycle 1 (28 days per cycle)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Notes [71] - FAS [72] - FAS |
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Subjects With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 | ||||||||||||||||||||||||
End point description |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At cycle 3 (28 days per cycle)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Notes [73] - FAS [74] - FAS |
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Screening | |||||||||||||||||||||||||||
End point description |
The investigator was asked to interview the subject and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
At screening (28 days)
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
Notes [75] - FAS [76] - FAS |
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle | |||||||||||||||||||||||||||
End point description |
The investigator was asked to interview the subject and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
At Baseline (28 days per cycle)
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
Notes [77] - FAS [78] - FAS |
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2 | |||||||||||||||||||||||||||
End point description |
The investigator was asked to interview the subject and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
At cycle 2 (28 days per cycle)
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
Notes [79] - FAS [80] - FAS |
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Missing Time From Work Due to Dysmenorrheic Pain at Final Examination | |||||||||||||||||||||||||||
End point description |
The investigator was asked to interview the subject and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
At final examination (28 days)
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
Notes [81] - FAS [82] - FAS |
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | ||||||||||||
End point description |
The subjects were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At screening (average over 3 months before screening)
|
||||||||||||
|
|||||||||||||
Notes [83] - FAS [84] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | ||||||||||||
End point description |
The subjects were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At screening (average over 3 months before screening)
|
||||||||||||
|
|||||||||||||
Notes [85] - FAS [86] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | ||||||||||||
End point description |
The subjects were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At screening (average over 3 months before screening)
|
||||||||||||
|
|||||||||||||
Notes [87] - FAS [88] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | ||||||||||||
End point description |
The subjects were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At screening (average over 3 months before screening)
|
||||||||||||
|
|||||||||||||
Notes [89] - FAS [90] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | ||||||||||||
End point description |
The subjects were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At screening (average over 3 months before screening)
|
||||||||||||
|
|||||||||||||
Notes [91] - FAS [92] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | ||||||||||||
End point description |
The subjects were asked to complete a resource use questionnaire indicating their own costs ofmedical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At screening (average over 3 months before screening)
|
||||||||||||
|
|||||||||||||
Notes [93] - FAS [94] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | ||||||||||||
End point description |
The subjects were asked to complete a resource use questionnaire indicating their other own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At screening (average over 3 months before screening)
|
||||||||||||
|
|||||||||||||
Notes [95] - FAS [96] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | ||||||||||||
End point description |
The subjects were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At screening (average over 3 months before screening)
|
||||||||||||
|
|||||||||||||
Notes [97] - FAS [98] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire | ||||||||||||
End point description |
The subjects were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At screening (average over 3 months before screening)
|
||||||||||||
|
|||||||||||||
Notes [99] - FAS [100] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Subjects With Improvement in the Investigators' Assessment in the Clinical Global Impression | |||||||||||||||||||||||||||||||||
End point description |
The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Investigators were asked to rate the subjects' improvement during the course of the study.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At cycle 2 (28 days per cycle)
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Notes [101] - FAS [102] - FAS |
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Subjects With Improvement in Subjects' Assessment in the Clinical Global Impression | |||||||||||||||||||||||||||||||||
End point description |
The CGI is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Subjects were asked to rate their improvement during the course of the study.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At cycle 2 (28 days per cycle)
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Notes [103] - FAS [104] - FAS |
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | ||||||||||||
End point description |
The standard questionnaire SF-36 version 1 (v1), a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At baseline cycle (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [105] - FAS [106] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | ||||||||||||
End point description |
The standard questionnaire SF-36 v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At final examination (28 days)
|
||||||||||||
|
|||||||||||||
Notes [107] - FAS [108] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At baseline cycle (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [109] - FAS [110] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At final examination (28 days)
|
||||||||||||
|
|||||||||||||
Notes [111] - FAS [112] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At baseline cycle (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [113] - FAS [114] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At final examination (28 days)
|
||||||||||||
|
|||||||||||||
Notes [115] - FAS [116] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At baseline cycle (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [117] - FAS [118] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At final examination (28 days)
|
||||||||||||
|
|||||||||||||
Notes [119] - FAS [120] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At baseline cycle (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [121] - FAS [122] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At final examination (28 days)
|
||||||||||||
|
|||||||||||||
Notes [123] - FAS [124] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At baseline cycle (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [125] - FAS [126] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At final examination (28 days)
|
||||||||||||
|
|||||||||||||
Notes [127] - FAS [128] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At baseline cycle (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [129] - FAS [130] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At final examination (28 days)
|
||||||||||||
|
|||||||||||||
Notes [131] - FAS [132] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At baseline cycle (28 days per cycle)
|
||||||||||||
|
|||||||||||||
Notes [133] - FAS [134] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination | ||||||||||||
End point description |
The standard questionnaire SF-36v1, a general health status measure used to evaluate subject populations and to compare health status across different populations, was completed by subjects as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At final examination (28 days)
|
||||||||||||
|
|||||||||||||
Notes [135] - FAS [136] - FAS |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From treatment period (on-treatment cycles 2 and 3, usually 56 days) up to end of study visit (visit 4, final examination, 28 days)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ethinyl Estradiol, Levonorgestrel (Miranova)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
|
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Reporting group description |
Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles. Subjects who received treatment were included in baseline period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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19 Feb 2009 |
Amendment 1 was globally implemented before the inclusion of the first subject in the study. As an adequate (re-)supply for the originally planned comparator (Alesse) was not considered feasible, Alesse was replaced by SH D593B (Miranova), and the originally intended encapsulation of tablets for blinding was replaced by a double-dummy design that was considered to have advantages for the subjects, study drug supply and the study as a whole. |
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26 Aug 2009 |
Amendment 2 was globally implemented to reflect revised rules to be observed in case of missed tablets to further improve readability. These revised rules had been submitted with the regulatory submission of SH T00658ID to the Food and Drug Administration (FDA) on 02 Jul 2009. In addition, according to the general recommendations for combined oral contraceptive users, the maximum age for smokers to be eligible for this study was changed from 30 to 35 years. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |