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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

This study has been completed.
Baylor College of Medicine
Information provided by:
Office of Rare Diseases (ORD) Identifier:
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: May 2000

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 Intervention Phase
Acanthosis Nigricans Polycystic Ovary Syndrome Drug: leuprolide acetate Drug: spironolactone Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date: July 1989
Estimated Study Completion Date: January 1996
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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


--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

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Please refer to this study by its identifier: NCT00004311

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Baylor College of Medicine
Study Chair: Karen E. Elkind-Hirsch Baylor College of Medicine
  More Information Identifier: NCT00004311     History of Changes
Other Study ID Numbers: 199/11816
Study First Received: October 18, 1999
Last Updated: June 23, 2005

Keywords provided by Office of Rare Diseases (ORD):
acanthosis nigricans
dermatologic disorders
endocrine disorders
polycystic ovarian syndrome
rare disease

Additional relevant MeSH terms:
Insulin Resistance
Polycystic Ovary Syndrome
Acanthosis Nigricans
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Pigmentation Disorders
Skin Diseases
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Mineralocorticoid Receptor Antagonists processed this record on August 18, 2017