Treatment of Infertility in Women With Polycystic Ovary Syndrome
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Polycystic Ovary Syndrome Infertility Pregnancy |
Intervention | Drug: metformin XR Drug: clomiphene citrate |
Phase | Phase 3 |
Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Responsible Party | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier | NCT00068861 |
First Received | September 10, 2003 |
Last Updated | September 28, 2007 |
Last verified | September 2005 |
Tracking Information[ + expand ][ + ]
First Received Date | September 10, 2003 |
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Last Updated Date | September 28, 2007 |
Start Date | November 2002 |
Estimated Primary Completion Date | February 2006 |
Current Primary Outcome Measures | Live birth rate |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Treatment of Infertility in Women With Polycystic Ovary Syndrome |
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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 |
Brief Summary | 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. |
Detailed Description | 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. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: metformin XR Drug: clomiphene citrate |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 678 |
Estimated Completion Date | February 2006 |
Estimated Primary Completion Date | Not Provided |
Eligibility Criteria | 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 | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00068861 |
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Other Study ID Numbers | NICHD-PPCOS |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Study Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | September 2005 |
Locations[ + expand ][ + ]
University of Alabama at Birmingham | Birmingham, Alabama, United States, 35249 |
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University of California at San Diego | La Jolla, California, United States, 92037 |
Stanford University | Stanford, California, United States, 94305 |
University of Colorado | Aurora, Colorado, United States, 80045 |
Wayne State | Detroit, Michigan, United States, 48201 |
University of Medicine and Dentistry New Jersey | Newark, New Jersey, United States, 07103 |
Penn State | Hershey, Pennsylvania, United States, 17033 |
University of Pennsylvania | Philadelphia, Pennsylvania, United States, 19104 |
University of Texas Southwestern Medical Center | Dallas, Texas, United States, 75390 |
Baylor College of Medicine | Houston, Texas, United States, 77030 |
Virginia Commonwealth University | Richmond, Virginia, United States, 23298 |