Status:
COMPLETED
Metformin and Oral Contraceptives in PCOS
Lead Sponsor:
Odense University Hospital
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
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 w...
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). Pati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00451568
Start Date
March 1 2007
End Date
April 1 2013
Last Update
April 13 2015
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark