NCT00004311

Phase II Study of the Effect of Leuprolide Acetate and Spironolactone on Insulin Resistance in Hyperandrogenic Women With Polycystic Ovarian Disease or Hyperandrogenism Insulin Resistance Acanthosis Nigricans Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: Female
• Age: 0 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acanthosis Nigricans
• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	leuprolide acetate
DRUG	spironolactone

Timeline

• Start date: 1989-07-01
• Completion: 1996-01-01
• First posted: 1999-10-19
• Last updated: 2005-06-24