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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00068861 |
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.
Condition | Intervention | Phase |
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Polycystic Ovary Syndrome Infertility Pregnancy |
Drug: metformin XR Drug: clomiphene citrate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 678 |
Study Start Date: | November 2002 |
Study Completion Date: | February 2006 |
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.
Ages Eligible for Study: | 18 Years to 39 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35249 | |
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
University of California at San Diego | |
La Jolla, California, United States, 92037 | |
United States, Colorado | |
University of Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Michigan | |
Wayne State | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
University of Medicine and Dentistry New Jersey | |
Newark, New Jersey, United States, 07103 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Penn State | |
Hershey, Pennsylvania, United States, 17033 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75390 | |
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23298 |
Study ID Numbers: | NICHD-PPCOS |
Study First Received: | September 10, 2003 |
Last Updated: | September 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00068861 |
Health Authority: | United States: Food and Drug Administration |
Infertility Gonadal Disorders Metformin Citric Acid Endocrine System Diseases Clomiphene Ovarian Diseases |
Genital Diseases, Male Cysts Genital Diseases, Female Polycystic Ovary Syndrome Endocrinopathy Ovarian Cysts |
Estrogen Antagonists Disease Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Selective Estrogen Receptor Modulators Pharmacologic Actions Adnexal Diseases |
Estrogen Receptor Modulators Neoplasms Hypoglycemic Agents Pathologic Processes Therapeutic Uses Syndrome Fertility Agents, Female Fertility Agents |