Official Title: “Pregnancy in Polycystic Ovary Syndrome: A 30 Week Double-Blind Randomized Trial of Clomiphene Citrate, Metformin XR, and Combined Clomiphene Citrate/Metformin XR For the Treatment of Infertility in Women With Polycystic Ovary Syndrome”

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 10% of women.

The primary symptoms of PCOS are menstrual irregularities, increased body and facial hair, acne, and infertility. This study will test a combination of medications in women with PCOS to determine which works best to overcome infertility.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study

PCOS is characterized by excess circulating androgen levels and chronic anovulation. The fundamental pathophysiologic defect is unknown, but PCOS is characterized by insulin resistance and compensatory hyperinsulinemia. Improvements in insulin sensitivity in PCOS women, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. Resumption of ovulation occurs in up to 70% of women treated for PCOS. This study will evaluate the safety and effectiveness of clomiphene citrate and metformin XR in achieving a successful pregnancy in infertile PCOS women.

Women with PCOS who are seeking pregnancy will be enrolled in this study. Women will be randomized to one of three different treatment arms: A) metformin XR 1000 mg twice/day; B) clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle); or C) metformin XR 1000 mg twice/day with clomiphene citrate 50 mg/day for 5 days (day 3-7 of cycle). Women will continue on study medications for 30 weeks, 6 treatment cycles, or until they become pregnant. Progesterone levels will be drawn weekly to monitor ovulation.

Intervention(s) in this Clinical Trial

• Drug: metformin XR
• Drug: clomiphene citrate

Primary Measures

• Live birth rate

Secondary Measures

• singleton live birth rate
• ovulation rate
• cycles to first ovulation
• cycles to conception
• abortion rate
• cycles to pregnancy
• weeks from pregnancy to live birth

Inclusion Criteria

• Eight or fewer menstrual cycles in the past year or intermenstrual periods of 45 days or longer
• Elevated testosterone level
• Good general health
• Sperm concentration in partner of 20 million/ml or greater
• Ability to have intercourse 2-3 times per week
• One functional fallopian tube and normal uterine cavity

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 39 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Child Health and Human Development (NICHD)

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00068861

Study ID Number: NICHD-PPCOS

ClinicalTrials.gov Identifier: NCT00068861

Health Authority: United States: Food and Drug Administration