A prospective randomised controlled trial comparing the effects of metformin with the 20 microgram ethinyl estradiol oral contraceptive pill on the hormonal and metabolic profiles in women with polycystic ovarian syndrome.

Recruiting

• Conditions: Polycystic Ovary Syndrome; Metabolic and Endocrine - Other metabolic and endocrine disorders

• Registration Number: ACTRN12605000219684
• Lead Sponsor: Michael Costello

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 36

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified