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Phase 2
N/A
N/A
Not Enrolling
Female
Acanthosis Nigricans, Polycystic Ovary Syndrome

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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

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