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.

Condition	Treatment or Intervention	Phase
Acanthosis Nigricans Polycystic Ovary Syndrome	Drug: leuprolide acetate  Drug: spironolactone	Phase II

Further Study Details: 

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.

Genders Eligible for Study:  Female

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Polycystic ovarian disease Oligomenorrhea or amenorrhea Hirsutism Hyperandrogenism Hyperandrogenism insulin resistance acanthosis nigricans syndrome Hyperandrogenism Oligomenorrhea or amenorrhea Insulin resistance Acanthosis nigricans Hematocrit at least 30% Women with normal menstrual cycles not using oral contraception entered as controls

Study chairs or principal investigators

Karen E. Elkind-Hirsch,  Study Chair,  Baylor College of Medicine   

Study ID Numbers:  199/11816; BCM-467
Record last reviewed:  May 2000
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004311
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08