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

Trial information Top of page
Trial identification
Sponsor protocol code	PCOS, metformin og p-piller 2006.
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Odense University Hospital
Sponsor organisation address	kløvervænget 6, Odense, Denmark, 5000
Public contact	Department of endocrinology, Odense University Hospital, department of endocrinology, 0045 65412502,
Scientific contact	Marianne Andersen, Odense University Hospital, department of endocrinology, 0045 65412502, msa@rsyd.dk
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	29 Oct 2020
Is this the analysis of the primary completion data?	Yes
Primary completion date	01 Sep 2013
Global end of trial reached?	Yes
Global end of trial date	01 Sep 2013
Was the trial ended prematurely?	No
General information about the trial
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
Protection of trial subjects	regional data monitoring comitee + ethical comitee + GCP unit
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	12 Oct 2007
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Denmark: 90
Worldwide total number of subjects	90
EEA total number of subjects	90
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	90
From 65 to 84 years	0
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	90 women aged 18-39 years fulfilling the Rotterdam criteria for PCOS were included in the study
Pre-assignment
Screening details	90 women aged 18-39 years fulfilling the Rotterdam criteria for PCOS were included in the study
Period 1
Period 1 title	overall trial (overall period)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Not blinded
Arms
Are arms mutually exclusive	Yes
Arm title	Meformin
Arm description	metformin
Arm type	Active comparator
Investigational medicinal product name	Metformin
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	1 g x 2
Arm title	oral contaceptive
Arm description	oral contraceptive
Arm type	Active comparator
Investigational medicinal product name	Oral contraceptive
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	21 active/ 7 day pause
Arm title	Metformin and Oral contraceptive
Arm description	Metformin and Oral contraceptive
Arm type	Active comparator
Investigational medicinal product name	Metformin
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	1 g x 2
Investigational medicinal product name	Oral contraceptive
Investigational medicinal product code
Other name
Pharmaceutical forms	Tablet
Routes of administration	Oral use
Dosage and administration details	21 day active/7 days pause
Number of subjects in period 1 Meformin oral contaceptive Metformin and Oral contraceptive Started 30 30 30 baseline 30 23 30 12 months 19 23 23 Completed 19 23 23 Not completed 11 7 7      Lost to follow-up 11 7 7

Subject disposition Top of page

Baseline characteristics Top of page

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Meformin
Reporting group description	metformin
Reporting group title	oral contaceptive
Reporting group description	oral contraceptive
Reporting group title	Metformin and Oral contraceptive
Reporting group description	Metformin and Oral contraceptive

End points Top of page

Primary: weight Top of page
End point title	weight
End point description
End point type	Primary
End point timeframe	12 months
End point values Meformin oral contaceptive Metformin and Oral contraceptive Number of subjects analysed 19 23 23 Units: kg     median (inter-quartile range (Q1-Q3)) -3 (-10.3 to 0.6) 1.2 (-0.8 to 3.0) -1.9 (-4.9 to 0.1)
Statistical analysis title	Statistical analysis
Comparison groups	Meformin v oral contaceptive v Metformin and Oral contraceptive
Number of subjects included in analysis	65
Analysis specification	Pre-specified
Analysis type	superiority
P-value	< 0.05
Method	Regression, Linear
Parameter type	Mean difference (final values)
Confidence interval

Primary: weight Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	12 months
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	1
Reporting groups
Reporting group title	Metformin
Reporting group description	-
Reporting group title	Metformin + oc
Reporting group description	-
Reporting group title	oral contraceptive
Reporting group description	-
Serious adverse events Metformin Metformin + oc oral contraceptive Total subjects affected by serious adverse events      subjects affected / exposed 0 / 30 (0.00%) 0 / 30 (0.00%) 0 / 30 (0.00%)      number of deaths (all causes) 0 0 0      number of deaths resulting from adverse events
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events Metformin Metformin + oc oral contraceptive Total subjects affected by non serious adverse events      subjects affected / exposed 1 / 30 (3.33%) 3 / 30 (10.00%) 3 / 30 (10.00%) Gastrointestinal disorders nausea      subjects affected / exposed 1 / 30 (3.33%) 3 / 30 (10.00%) 3 / 30 (10.00%)      occurrences all number 1 3 3

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported
Online references
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

More information Top of page