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 - Full Text View

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.

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Baylor College of Medicine
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004311

Purpose

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 II

ChemIDplus related topics:

Insulin Leuprolide acetate Leuprolide Spironolactone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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.

Eligibility

Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Study ID Numbers:	199/11816, BCM-467
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004311
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

acanthosis nigricans

dermatologic disorders

endocrine disorders

polycystic ovarian syndrome

rare disease

Study placed in the following topic categories:

Hyperpigmentation

Metabolic Diseases

Skin Diseases

Gonadal Disorders

Rare Diseases

Endocrine System Diseases

Hyperandrogenism

Ovarian Diseases

Acanthosis nigricans

Cysts

Acanthosis Nigricans

Insulin

Spironolactone

Genital Diseases, Female

Hyperinsulinism

Leuprolide

Polycystic Ovary Syndrome

Endocrinopathy

Insulin Resistance

Melanosis

Metabolic disorder

Glucose Metabolism Disorders

Ovarian Cysts

Additional relevant MeSH terms:

Disease

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Pigmentation Disorders

Hormone Antagonists

Diuretics

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents

Cardiovascular Agents

Pharmacologic Actions

Adnexal Diseases

Neoplasms

Pathologic Processes

Aldosterone Antagonists

Natriuretic Agents

Fertility Agents, Female

Therapeutic Uses

Syndrome

Fertility Agents

ClinicalTrials.gov processed this record on September 05, 2008