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Clinical Trial Summary

OBJECTIVES: I. Evaluate insulin resistance in thin and obese hyperandrogenic women with polycystic ovarian disease or hyperandrogenism insulin resistance acanthosis nigricans syndrome and in thin and obese controls, using an estimation of tissue sensitivity to insulin.

II. Evaluate the effect of androgen suppression with leuprolide acetate and spironolactone on insulin secretion and resistance.


Clinical Trial Description

PROTOCOL OUTLINE: Participants are treated with subcutaneous leuprolide acetate followed by oral spironolactone. Each treatment is administered daily for 6 weeks, with a 6-week washout between drugs.

Patients and controls are alternately assigned to begin treatment with leuprolide acetate or spironolactone. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00004311
Study type Interventional
Source Office of Rare Diseases (ORD)
Contact
Status Completed
Phase Phase 2
Start date July 1989
Completion date January 1996

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