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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Metformin
• Drug: Yasmin

Primary Measures

• Changes in fasting insulin and area under the curve for insulin (2 hours)

Secondary Measures

• Changes in 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

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Odense University Hospital

Overall Clinical Trial Officials and Contacts

Marianne Andersen, MD, PhD Principal Investigator Odense University Hospital  

Overall Contact: Dorte Glintborg, MD, PhD +45 6541 1769 dorte.glintborg@dadlnet.dk

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00451568

Study ID Number: 027

ClinicalTrials.gov Identifier: NCT00451568

Health Authority: Denmark: National Board of Health