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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Virginia |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00005654 |
Purpose
OBJECTIVES:
I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome.
| Condition | Intervention |
|---|---|
|
Hyperinsulinism Polycystic Ovary Syndrome |
Drug: clomiphene citrate Drug: metformin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Estimated Enrollment: | 88 |
| Study Start Date: | January 2000 |
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 (arm I) or oral placebo (arm II) three times daily for 8 weeks. All patients who do not ovulate by day 28 receive oral clomiphene citrate daily on days 36-40.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Obese women with chronic anovulation due to polycystic ovary syndrome (PCOS)
Must have oligoamenorrhea and hyperandrogenemia
--Prior/Concurrent Therapy--
At least 2 months since prior standard therapy (including over the counter drugs) At least 2 months since prior investigational agents
--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 Fasting 17 alpha-hydroxy progesterone less than 200 mg/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency
Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception 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
Contacts and Locations More Information
| Study ID Numbers: | 199/14914, UVA-WSE023 |
| Study First Received: | May 2, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00005654 History of Changes |
| Health Authority: | United States: Federal Government |
|
endocrine disorders hyperinsulinism polycystic ovarian syndrome rare disease |
|
Gonadal Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Clomiphene Ovarian Diseases Selective Estrogen Receptor Modulators Hormones Polycystic Ovarian Syndrome Genital Diseases, Female Hyperinsulinism Estrogen Receptor Modulators Metabolic Disorder Obesity |
Estrogens Estrogen Antagonists Metabolic Diseases Metformin Citric Acid Rare Diseases Endocrine System Diseases Cysts Polycystic Ovary Syndrome Endocrinopathy Glucose Metabolism Disorders Ovarian Cysts |
|
Gonadal Disorders Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Clomiphene Ovarian Diseases Reproductive Control Agents Selective Estrogen Receptor Modulators Genital Diseases, Female Hyperinsulinism Estrogen Receptor Modulators Pathologic Processes Therapeutic Uses Syndrome |
Estrogen Antagonists Metabolic Diseases Disease Endocrine System Diseases Cysts Pharmacologic Actions Adnexal Diseases Neoplasms Fertility Agents, Female Polycystic Ovary Syndrome Fertility Agents Glucose Metabolism Disorders Ovarian Cysts |
