EFFECT OF INS 1 ON INSULIN &OVARIAN ANDROGEN PROD IN OBESE WOMEN W/PCOS

$30,487M01FY2000RRNIH

Boston University Medical Campus, Boston MA

Investigators

Linked publications & trials

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Abstract

A multicenter, randomized, placebo controlled, double blind, dose-ranging study. The objectives of this study are to confirm the results of INSMED study INS-1/6 in which oral administration of INS-1 (1200 mg/day) safely and effectively improved the underlying hyperinsulinemia, hyperandrogenism, and anovulation associated with PCOS & to examine lower doses (300 & 600 mg/day) of INS-1 to determine the dose response profile. Eighty obese [Body Mass Index (BMI)=28-35 kg/m2] women diagnosed with Polycystic Ovary Syndrome will be enrolled. The following treatment groups will take their respective study treatment in immediate release gelatin capsules once a day for 6 to 8 weeks: placebo 300, 600, & 1200 mg INS-1.

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