Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
Overview[ - collapse ][ - ]
| Purpose | OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome. |
|---|---|
| Condition | Polycystic Ovary Syndrome Hyperinsulinism |
| Intervention | Drug: clomiphene citrate Drug: metformin |
| Phase | N/A |
| Sponsor | National Center for Research Resources (NCRR) |
| Responsible Party | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier | NCT00005104 |
| First Received | April 6, 2000 |
| Last Updated | June 23, 2005 |
| Last verified | December 2003 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 6, 2000 |
|---|---|
| Last Updated Date | June 23, 2005 |
| Start Date | January 2000 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome |
|---|---|
| Official Title | Not Provided |
| Brief Summary | OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome. |
| Detailed Description | PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms. Patients receive oral metformin or oral placebo three times daily for 7 weeks. Patients remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110. Following ovulation, treatment with clomiphene citrate and metformin or placebo continues until 6 ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients receiving the placebo arm who have not ovulated on the highest dose of clomiphene citrate may be crossed over to receive metformin after a 6 week washout. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: clomiphene citrate Drug: metformin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 99 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Patients with chronic anovulation due to polycystic ovary syndrome (PCOS) who have failed clomiphene citrate Must have oligoovulation and hyperandrogenemia --Prior/Concurrent Therapy-- Endocrine therapy: At least 2 months since prior clomiphene citrate Other: - At least 2 months since prior standard therapy (including over the counter drugs) - At least 2 months since prior investigational drugs - Prior multi/prenatal vitamins allowed --Patient Characteristics-- Hematopoietic: Hematocrit greater than 38% Hepatic: - Liver function normal - No clinically significant hepatic disease Renal: - No clinically significant renal disease - Creatinine less than 1.4 mg/dL - No proteinuria Cardiovascular: No clinically significant cardiac disease Pulmonary: No clinically significant pulmonary disease Hormonal: - Thyroid function normal - Prolactin normal - Estradiol normal - Fasting 17 alpha-hydroxy progesterone less than 200 ng/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency Other: - Not pregnant - Negative pregnancy test - Male partner must have a normal semen analysis by WHO criteria - Must be in acceptable health by interview, medical history, physical exam, and laboratory tests - No diabetes mellitus - No clinically significant neurologic, psychiatric, infectious, neoplastic, or metabolic disease - No clinically significant malignant disease except nonmelanomatous skin cancer - At least 1 year since any prior drug abuse or alcoholism |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Italy |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00005104 |
|---|---|
| Other Study ID Numbers | 199/14915 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | National Center for Research Resources (NCRR) |
| Study Sponsor | National Center for Research Resources (NCRR) |
| Collaborators | University of Virginia |
| Investigators | Study Chair: William S. Evans University of Virginia |
| Verification Date | December 2003 |
Locations[ + expand ][ + ]
| University of Alabama at Birmingham | Birmingham, Alabama, United States, 35294-3300 |
|---|---|
| Louisiana State University School of Medicine | Shreveport, Louisiana, United States, 71130-3932 |
| Washington University - St. Louis | St. Louis, Missouri, United States, 63110 |
| University of Virginia | Charlottesville, Virginia, United States, 22908 |
| Medical College of Virginia School of Medicine | Richmond, Virginia, United States, 23298-0230 |
| University Alma Mater | Bologna, Italy, 40100 |