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
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.
|Acanthosis Nigricans Polycystic Ovary Syndrome||Drug: leuprolide acetate Drug: spironolactone||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||July 1989|
|Estimated Study Completion Date:||January 1996|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004311
|Study Chair:||Karen E. Elkind-Hirsch||Baylor College of Medicine|