Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome

National Center for Research Resources (NCRR)0 个研究点目标入组 88 人开始时间: 2000年1月1日最近更新: 2005年6月24日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 88

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•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

排除标准

未提供

研究者

发起方

National Center for Research Resources (NCRR)

申办方类型

Nih

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已完成

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