Trial Information
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Karen E. Elkind-Hirsch
Investigator Role:
Study Chair
Investigator Affiliation:
Baylor College of Medicine
Authority:
United States: Federal Government
Study ID:
199/11816
NCT ID:
NCT00004311
Start Date:
July 1989
Completion Date:
January 1996
Related Keywords:
- Acanthosis Nigricans
- Polycystic Ovary Syndrome
- acanthosis nigricans
- dermatologic disorders
- endocrine disorders
- polycystic ovarian syndrome
- rare disease
- Acanthosis Nigricans
- Insulin Resistance
- Polycystic Ovary Syndrome
