Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2010-01-31

Brief Summary

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The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS

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Detailed Description

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Inclusion criteria: PCOS women between the ages of 18-45,\< 8 periods annually, elevated serum free testosterone, normal thyroid function tests and serum prolactin, exclusion of late onset adrenal hyperplasia, acceptable health based on interview and medical history, physical exam and lab tests, ability to comply with the requirements of the study and to provide signed, witnessed informed consent.

Conditions

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Polycystic Ovary Syndrome PCOS Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Placebo tablet and birth control pill daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo birth control pill daily

2

metformin 2000 mg and birth control pill daily

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

2000 mg per day for 3 months daily birth control pill

Interventions

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placebo

placebo birth control pill daily

Intervention Type DRUG

metformin

2000 mg per day for 3 months daily birth control pill

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia

Exclusion Criteria

* Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes