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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

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ClinicalTrials.gov Identifier: NCT00004311
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
Office of Rare Diseases (ORD)

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.


Condition or disease Intervention/treatment Phase
Acanthosis Nigricans Polycystic Ovary Syndrome Drug: leuprolide acetate Drug: spironolactone Phase 2

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 Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : July 1989
Study Completion Date : January 1996

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


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004311


Sponsors and Collaborators
National Center for Research Resources (NCRR)
Baylor College of Medicine
Investigators
Study Chair: Karen E. Elkind-Hirsch Baylor College of Medicine

ClinicalTrials.gov Identifier: NCT00004311     History of Changes
Other Study ID Numbers: 199/11816
BCM-467
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2000

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

Additional relevant MeSH terms:
Acanthosis Nigricans
Syndrome
Insulin Resistance
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Spironolactone
Leuprolide
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents