Clinical Trial Results:
A non-blinded randomised trial on the effect of metformin vs.
metformin and oral contraceptives vs. oral contraceptives on
glucosetolerance, insulin resistance, growth hormone and cortisol metabolism in polycystic ovary syndrome
Summary
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EudraCT number |
2006-004763-57 |
Trial protocol |
DK |
Global end of trial date |
01 Sep 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Nov 2020
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First version publication date |
22 Nov 2020
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Other versions |
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 |
PCOS, metformin og p-piller 2006.
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Odense University Hospital
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Sponsor organisation address |
kløvervænget 6, Odense, Denmark, 5000
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Public contact |
Department of endocrinology, Odense University Hospital, department of endocrinology, 0045 65412502,
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Scientific contact |
Marianne Andersen, Odense University Hospital, department of endocrinology, 0045 65412502, msa@rsyd.dk
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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 |
29 Oct 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Sep 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Sep 2013
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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 compare the effects of oral contraceptives vs. metformin vs. metformin and oral contraceptives in patients with polycystic ovary syndrome on two points:
Insulin resistance
Glucose tolerance
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Protection of trial subjects |
regional data monitoring comitee + ethical comitee + GCP unit
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Oct 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 90
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Worldwide total number of subjects |
90
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EEA total number of subjects |
90
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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) |
90
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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 |
90 women aged 18-39 years fulfilling the Rotterdam criteria for PCOS were included in the study | ||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
90 women aged 18-39 years fulfilling the Rotterdam criteria for PCOS were included in the study | ||||||||||||||||||||||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Meformin | ||||||||||||||||||||||||||||
Arm description |
metformin | ||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Metformin
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Investigational medicinal product code |
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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 |
1 g x 2
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Arm title
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oral contaceptive | ||||||||||||||||||||||||||||
Arm description |
oral contraceptive | ||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Oral contraceptive
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Investigational medicinal product code |
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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 |
21 active/ 7 day pause
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Arm title
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Metformin and Oral contraceptive | ||||||||||||||||||||||||||||
Arm description |
Metformin and Oral contraceptive | ||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Metformin
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Investigational medicinal product code |
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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 |
1 g x 2
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Investigational medicinal product name |
Oral contraceptive
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Investigational medicinal product code |
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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 |
21 day active/7 days pause
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End points reporting groups
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Reporting group title |
Meformin
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Reporting group description |
metformin | ||
Reporting group title |
oral contaceptive
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Reporting group description |
oral contraceptive | ||
Reporting group title |
Metformin and Oral contraceptive
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Reporting group description |
Metformin and Oral contraceptive |
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End point title |
weight | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 months
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Statistical analysis title |
Statistical analysis | ||||||||||||||||
Comparison groups |
Meformin v oral contaceptive v Metformin and Oral contraceptive
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Number of subjects included in analysis |
65
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
Regression, Linear | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
12 months
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Assessment type |
Systematic | ||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Metformin
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Reporting group description |
- | ||||||||||||||||||||||||||||
Reporting group title |
Metformin + oc
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Reporting group description |
- | ||||||||||||||||||||||||||||
Reporting group title |
oral contraceptive
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Reporting group description |
- | ||||||||||||||||||||||||||||
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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? No | |||
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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/33112812 http://www.ncbi.nlm.nih.gov/pubmed/29658344 http://www.ncbi.nlm.nih.gov/pubmed/28834135 http://www.ncbi.nlm.nih.gov/pubmed/28432082 http://www.ncbi.nlm.nih.gov/pubmed/26194691 http://www.ncbi.nlm.nih.gov/pubmed/24906976 http://www.ncbi.nlm.nih.gov/pubmed/24742124 |