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.

Project Start
1999-12-01
Project End
2000-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
32
Fiscal Year
2000
Total Cost
$30,487
Indirect Cost
Name
Boston University
Department
Type
DUNS #
604483045
City
Boston
State
MA
Country
United States
Zip Code
02118
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