Clinical Trial Results:
A prospective, randomized, parallel-group study to assess the effects on ovarian activity of ellaOne (ulipristal acetate 30 mg single dose) taken after three consecutive days of missed combined oral contraceptive pills
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Summary
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EudraCT number |
2017-002283-41 |
Trial protocol |
DE |
Global end of trial date |
28 May 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
19 May 2019
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First version publication date |
19 May 2019
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Other versions |
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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 |
151032-002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Laboratoire HRA Pharma
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Sponsor organisation address |
200 avenue de Paris, Chatillon, France, 92320
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Public contact |
Marlène Perret, Laboratoire HRA Pharma, 0033 184139257, m.perret@hra-pharma.com
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Scientific contact |
Marlène Perret, Laboratoire HRA Pharma, 0033 184139257, m.perret@hra-pharma.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 |
25 Feb 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 May 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
28 May 2018
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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 |
To explore the pharmacodynamic (PD) effects, and specifically on occurrence and timing of ovulation with pregnancy risk, of ellaOne taken after pills of combined oral contraception (COC) were missed for three consecutive days during the first week of COC use and were resumed either on the day of ellaOne intake or five days later.
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Protection of trial subjects |
Subjects had to be withdrawn from study medication under the following circumstances:
• Pregnancy (every attempt must be made to follow up subjects who become pregnant to determine the outcome of the pregnancy),
• Serious intercurrent problems requiring admission to the critical care unit or surgery,
• Subject unable to comply with study visits or requirements,
• Suspected unexpected serious adverse reaction to study medication,
• Subject withdraws informed consent,
• Liver enzymes levels above three times the upper limit of normal at D1 or D15 of the EXP period,
• Upon discretion of the investigator in the event of a protocol violation (inclusion/ exclusion criteria).
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Background therapy |
no Background therapy | ||
Evidence for comparator |
No comparator | ||
Actual start date of recruitment |
08 Jan 2018
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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 |
Germany: 65
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Worldwide total number of subjects |
65
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EEA total number of subjects |
65
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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) |
0
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Adults (18-64 years) |
65
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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 |
The screening period was performed within a maximum of 28 days before start of Baseline period. The Baseline period was performed after all screening assessments are checked by the investigator. The Baseline period was from D1 to D28. The randomization was performed at D29 (= V2: D1: 1st day of the Experimental period) | ||||||||||||||||||
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Pre-assignment
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Screening details |
The women screened had a BMI <30.0 kg/m2, relied on a COC as their primary method of contraception for at least 2 cycles before they enter the baseline (B) period and were willing to continue with a COC for at least 1 cycle after end of experimental (EXP) period, must not be at risk of pregnancy and were willing to use condoms during the study. | ||||||||||||||||||
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Period 1
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Period 1 title |
Baseline period
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||||
Roles blinded |
Assessor [1] | ||||||||||||||||||
Blinding implementation details |
The study is single-blind but blinding will be kept only until End of Study visit for the study site personnel in charge of performing TransVaginal Ultrasound (TVU).
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Arms
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Arm title
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Baseline | ||||||||||||||||||
Arm description |
- | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Levora®
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Investigational medicinal product code |
Levora®
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Baseline period:
- 1 active pill of Levora® (30 µg ethinyl estradiol / 150 µg levonorgestrel) taken every day during 21 days from D1 to D21 evenings.
- 1 inactive pill of Levora® taken every day during 7 days from D22 to D28 evenings.
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| Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: The study is single-blind but blinding will be kept only until End of Study visit for the study site personnel in charge of performing TransVaginal Ultrasound (TVU). |
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Period 2
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Period 2 title |
Experimental period
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Is this the baseline period? |
No | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||||
Roles blinded |
Assessor [2] | ||||||||||||||||||
Blinding implementation details |
The study is single-blind but blinding will be kept only until End of Study visit for the study site personnel in charge of performing TransVaginal Ultrasound (TVU).
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Arm1: COC resumed on the day of UPA intake | ||||||||||||||||||
Arm description |
Immediate resumption of combined oral contraception (COC) after pills of COC were missed for 3 consecutive days | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
ellaOne® 30 mg
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Investigational medicinal product code |
UPA 30 mg
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Other name |
ella® 30 mg, ulipristal acetate 30 mg
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Arm1 / Arm 2:
- 1 pill of 30 mg UPA taken at D8 morning.
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Investigational medicinal product name |
Levora®
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Investigational medicinal product code |
Levora®
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Arm 1 / Experimental period:
- 1 active pill of Levora® (30 µg ethinyl estradiol / 150 µg levonorgestrel) taken every day during 4 days from D1 to D4 evenings (Theoretical time of ella intake + 12h (+/- 30 min)).
- 1 active pill of Levora taken 12 hours (+/- 30 min) after ellaOne theoretical time of intake (i.e. on D8 evening), and 1 pill taken every day during 13 days, from D9 evening until D21 evening.
- 1 inactive pill of Levora® taken every day during 7 days from D22 to D28 evenings.
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Arm title
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Arm 2: COC resumed 5 days after UPA intake | ||||||||||||||||||
Arm description |
Resumption of combined oral contraception (COC) after pills of COC were missed for 8 consecutive days (3+5 days). | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
ellaOne® 30 mg
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Investigational medicinal product code |
UPA 30 mg
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Other name |
ella® 30 mg, ulipristal acetate 30 mg
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Arm 1 / Arm 2:
- 1 pill of 30 mg UPA taken at D8 morning in EXP period.
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Investigational medicinal product name |
Levora®
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Investigational medicinal product code |
Levora®
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Arm 2 / Experimental period:
- 1 active pill of Levora (30 μg ethinyl estradiol / 150 μg levonorgestrel) taken every day during 4 days from D1 to D4 evenings (Theoretical time of ella intake + 12h (+/- 30 min)).
- 1 active pill of Levora taken 5 days and 12hours (+/- 30 min) after ellaOne® theoretical time of intake (i.e. on D13 evening).
- 1 active pill of Levora taken every evening during 8 days, from D14 evening until D21 evening.
- 1 inactive pill of Levora® taken every day during 7 days from D22 to D28 evenings.
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| Notes [2] - The roles blinded appear inconsistent with a simple blinded trial. Justification: The study is single-blind but blinding will be kept only until End of Study visit for the study site personnel in charge of performing TransVaginal Ultrasound (TVU). |
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Baseline characteristics reporting groups
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Reporting group title |
Baseline
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Arm1: COC resumed on the day of UPA intake
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All women who completed the study in Arm 1
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Subject analysis set title |
Arm 2: COC resumed 5 days after UPA intake
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All women who completed the study in Arm 2
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End points reporting groups
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Reporting group title |
Baseline
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Reporting group description |
- | ||
Reporting group title |
Arm1: COC resumed on the day of UPA intake
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Reporting group description |
Immediate resumption of combined oral contraception (COC) after pills of COC were missed for 3 consecutive days | ||
Reporting group title |
Arm 2: COC resumed 5 days after UPA intake
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Reporting group description |
Resumption of combined oral contraception (COC) after pills of COC were missed for 8 consecutive days (3+5 days). | ||
Subject analysis set title |
Arm1: COC resumed on the day of UPA intake
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All women who completed the study in Arm 1
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Subject analysis set title |
Arm 2: COC resumed 5 days after UPA intake
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All women who completed the study in Arm 2
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End point title |
Proportion of women at risk of pregnancy (OSp) during the EXP period | |||||||||
End point description |
Analysis 1: Proportion of women randomized, treated with ellaOne® and having completed their experimental period in Full Analysis Set either in arm 1 or arm 2 and who were (at any time from D1 to D28 during the Experimental period) an Ovarian Status at risk of Pregnancy
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End point type |
Primary
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End point timeframe |
At any time from D1 to D28 during the Experimental period
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Statistical analysis title |
Proportion of women who were at risk of pregnancy | |||||||||
Statistical analysis description |
Proportion was estimated with their exact (Clopper-Pearson) two-sided 95% confidence interval.
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Comparison groups |
Arm1: COC resumed on the day of UPA intake v Arm 2: COC resumed 5 days after UPA intake
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
= 0.042 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
- | |||||||||
upper limit |
- | |||||||||
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End point title |
The time to ovulation with risk of pregnancy (time to OSp) | |||||||||
End point description |
Analysis 2: Evolution over time of the estimated probability of being ovulation free (K-M curves) was presented using the of time to event of each women.
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End point type |
Primary
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End point timeframe |
At any time from D1 to D28 during the Experimental period
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Statistical analysis title |
Time to ovulation of women with risk of pregnancy | |||||||||
Statistical analysis description |
Evolution over time of the estimated probability of being ovulation free was presented using the Kaplan Mieir approach survival curves (proportion of event free women at each day) in each arm and use of the non-parametric logrank test for comparing both groups in the FAS population.
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Comparison groups |
Arm1: COC resumed on the day of UPA intake v Arm 2: COC resumed 5 days after UPA intake
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
= 0.028 | |||||||||
Method |
Logrank | |||||||||
Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
- | |||||||||
upper limit |
- | |||||||||
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End point title |
The proportion of women who ovulated within the five days following ellaOne intake and were at risk of pregnancy (OSp) during the EXP period | |||||||||
End point description |
Analysis 3: Proportion of women randomized, treated with ellaOne® and having completed their experimental period in Full Analysis Set either in arm 1 or arm 2 and who ovulated within the five days following ellaOne intake and were at risk of pregnancy (OSp) during the EXP period
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End point type |
Secondary
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End point timeframe |
At any time from D1 to D28 during the Experimental period
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Statistical analysis title |
Proportion of women who ovulated in 5 days | |||||||||
Statistical analysis description |
Proportion was estimated with their exact (Clopper-Pearson) two-sided 95% confidence interval.
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Comparison groups |
Arm1: COC resumed on the day of UPA intake v Arm 2: COC resumed 5 days after UPA intake
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
= 1 [1] | |||||||||
Method |
Fisher exact | |||||||||
Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
- | |||||||||
upper limit |
- | |||||||||
| Notes [1] - Arm 1: 0% 95%CI [0 – 13.22] Arm 2: 0% 96% CI [0 – 14.8] |
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End point title |
Occurrence rate of ovulation (from D1 to D28) at risk of pregnancy (OSp) during BSL period | |||||||||
End point description |
Analysis 4: Proportion of women randomized, having missed three consecutive pills of COC, having completed their baseline period in Full Analysis Set either in arm 1 or arm 2 and show the occurrence rate of ovulation (from D1 to D28) at risk of pregnancy (OSp) during BSL period
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End point type |
Secondary
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End point timeframe |
At any time from D1 to D28 during the baseline period
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Statistical analysis title |
Occurrence rate of ovulation at OSp during BSL | |||||||||
Statistical analysis description |
Rate will be estimated with its exact (Clopper-Pearson) two-sided 95% confidence interval.
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Comparison groups |
Arm1: COC resumed on the day of UPA intake v Arm 2: COC resumed 5 days after UPA intake
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
= 1 [2] | |||||||||
Method |
Fisher exact | |||||||||
Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
- | |||||||||
upper limit |
- | |||||||||
| Notes [2] - NA |
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Adverse events information
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Timeframe for reporting adverse events |
From the signature of the informed consent (from screening visit) to the last visit (end of study visit V7) planned in the protocol.
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Adverse event reporting additional description |
Adverse events observed by the investigator or reported by the subject will be collected
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
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Reporting groups
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Reporting group title |
Safety set - All subjects
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Reporting group description |
All the subjects included in analysis from D1 Baseline to end of study visit (V7) with informed consent signed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Safety Set - Arm 1
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Reporting group description |
All women included in arm 1 who completed the study (arm 1 of the Full Analysis Set ) from D1 Baseline to end of study visit (V7) with informed consent signed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Safety Set - Arm 2
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Reporting group description |
All women included in arm 2 who completed the study (arm 2 of the Full Analysis Set ) from D1 Baseline to end of study visit (V7) with informed consent signed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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07 Dec 2017 |
Protocol dated on 07 December 2017 included additional specific:
- Monitoring of Liver function test : Laboratory safety parameters (ALAT, ASAT, GGT, ALP, total bilirubin) were measured in addition to the screening, the following visits, on Day 1 and Day 15 of the Experimental period and at End-of-Study visit.
- Exclusion criteria related to liver function and global study termination rules:
Subjects presenting with any of the following were not to be included in the study: Liver enzymes levels at the screening visit above three times the upper limit of normal or any other anomalies in safety labs recognized as clinically significant by the investigator.
For more additional information, please see section Interruption below. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? Yes | |||||||
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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 | |||||||
