Metformin and Oral Contraceptives in PCOS

April 10, 2015 updated by: Marianne Andersen, Odense University Hospital

Background: PCOS is a common condition with a prevalence of 5-8 % in premenopausal women. More than 50% of PCOS patients are insulin resistant and have a diabetes risk 5-8 times higher than age- and weight-matched controls. Studies using insulin sensitizers in PCOS found increased insulin sensitivity and decreased insulin levels to be followed by decreased androgen levels and improved ovulatory function. No studies however, evaluated the long term effects of insulin sensitizing treatment.

Oral contraceptives normalize menstrual cycles and suppress androgen levels in PCOS, however no long-term studies evaluated the effects of combined treatment with metformin and oral contraceptives in PCOS.

Design: Randomized open study in 3*30 PCOS patients. Patients are randomised to 24 months of treatment with 1: metformin, 2: metformin and oral contraceptives or 3: oral contraceptives.

Primary outcome measures: fasting insulin, AUC insulin. Secundary endpoints: BMI, WHR, LH, FSH, total and free-testosterone, c-peptid, urinary cortisol, AUC for insulin, glucose and c-peptid during OGTT.

Inclusioncriteria:

  1. Irregular menses or anovulaty cycles
  2. High free testosterone > 0,035 nmol/l or hirsutism
  3. PCO in vaginal US Criteria 1 and 2 OR 2 and 3.

Design:

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

90 patients are included and randomized to 12 months of treatment with metformin (1000+1000 mg/d) or OCP (150 mg desogestrel 30 microgram ethinylestradiol) or combined treatment (metformin+OCP).

Patients attend a biochemical and physical examination at study inclusion and at 12 months. Patients attend for registration of side effects and compliance after 6 months of study duration. Safety tests are performed at all three visits and include weight, blood pressure, HbA1c, liver enzymes, electrolytes, and white blood cell count. Pregnancy tests are performed by the participants each month. Patients are given general advice on lifestyle intervention. Patients are excluded if they initiated medical treatment with possible hormonal and metabolic effects during the intervention period. Lifestyle intervention is allowed. Laser treatment is offered to patients with moderate or severe facial hirsutism and patients are allowed to shave/wax. The patients accept not applying cosmetic treatment 3-4 days before attending for evaluation at the clinic.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Irregular menses or anovulaty cycles
  • High free testosterone > 0.035 nmol/l or hirsutism
  • PCO in vaginal US Criteria 1 and 2 OR 2 and 3

Exclusion Criteria:

  • Age > 18 years
  • Postmenopausal
  • Diagnosis diabetes mellitus
  • Use of medicine known to affect hormones measured in the project
  • Pregnancy or planned pregnancy during study period
  • Non-Caucasian
  • Previous tromboembolic disease
  • Heavy smoker > 35 years and BMI > 35 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
metformin
Drug: Metformin
500 mg 2 tablets 2 times a day
Active Comparator: 2
desorelle
Drug: Desorelle
1 tablet/day in 21 days
Active Comparator: 3
desorelle + metformin
Drug: Metformin
500 mg 2 tablets 2 times a day
Drug: Desorelle
1 tablet/day in 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in fasting insulin and area under the curve for insulin (2 hours)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in BMD, BMI, WHR, LH, FSH, total and free testosterone, fasting blood glucose, fasting C-peptide, urine-cortisol secretion, body composition, number of hypoglycaemic cases, AUC for insulin, glucose and C-peptide during OGTT (2 and 5 ho
Time Frame: 12 months
12 months
Changes in cortisol metabolism
Time Frame: 12 months
12 months
Changes in the prevalence of reactive hypoglycemia and areal under the curve for glucose (5 hours)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Marianne Andersen, MD, PhD, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 22, 2007

First Submitted That Met QC Criteria

March 22, 2007

First Posted (Estimate)

March 23, 2007

Study Record Updates

Last Update Posted (Estimate)

April 13, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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