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

Descriptive Information
Brief Title ^†	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
Official Title ^†
Brief 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.
Study Phase	Phase 2
Study Type ^†	Interventional
Study Design ^†	Primary Purpose: Treatment
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Acanthosis Nigricans Polycystic Ovary Syndrome
Intervention ^†	Drugleuprolide acetate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Drug
Estimated Enrollment ^†
Start Date ^†	July 1989
Completion Date	January 1996
Primary Completion Date
Eligibility 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
Gender	Female
Ages	N/A - N/A
Accepts Healthy Volunteers	No
Contacts ^††	, , , ,
Location Countries ^†
Administrative Information
NCT ID ^†	NCT00004311
Organization ID	199/11816
Secondary IDs ^††	BCM-467
Responsible Party	,
Study Sponsor ^†	National Center for Research Resources (NCRR)
Collaborators ^††	Baylor College of Medicine
Investigators ^†	Study Chair: Karen E. Elkind-Hirsch, Baylor College of Medicine
Information Provided By	Office of Rare Diseases (ORD)
Verification Date	May 2000
First Received Date ^†	October 18, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.