None listed
Conditions
Interventions
Intervention is metformin for 6 months.
Sponsors
Michael Costello
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
1. Obese (BMI > 28kg/m2) or non-obese (BMI < 28kg/m2) PCOS as defined above2. Amenorrhea or oligo-amenorrhea3. No contraindications to OCP a) History of, or current, thrombophlebitis, thromboembolic disorders and conditions which predispose to such diseases including venous thromboembolism. b) History of, or existing, cerebral vascular/ coronary artery disease c) Known or suspected carcinoma of the breast or the endometrium or a history of these d) Impaired liver function or active liver disease e) Undiagnosed abnormal vaginal bleeding f) Known or suspected pregnancy g) Women older than 35yrs age with hypertension, diabetes, or who smoke 4. No contraindications to metformin a) hypersensitivity to metformin or other biguanides b) diminished renal function c) cardiovascular disease (e.g. coronary insufficiency, myocardial infarction) d) severe hepatic dysfunction e) pancreatitis f) excessive alcohol intake g) concomitant use of diuretics5. No medications (including hormones) known to alter gonadal function, carbohydrate metabolism, or lipoprotein metabolism taken during the two months preceding the study6. Each woman to give informed consent to participate in the study.
Exclusion criteria
1. Diabetes mellitis2. Wishing to conceive.
Outcome results
None listed