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.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	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

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

Drug Information available for: Spironolactone Leuprolide Leuprolide acetate

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	199/11816, BCM-467
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004311 History of Changes
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

Additional relevant MeSH terms:

Antineoplastic Agents
Gonadal Disorders
Hormone Antagonists
Physiological Effects of Drugs
Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Ovarian Diseases
Genital Diseases, Female
Hyperinsulinism
Pathologic Processes
Leuprolide
Therapeutic Uses
Syndrome
Melanosis

Hyperpigmentation
Metabolic Diseases
Disease
Antineoplastic Agents, Hormonal
Skin Diseases
Pigmentation Disorders
Endocrine System Diseases
Cardiovascular Agents
Cysts
Acanthosis Nigricans
Pharmacologic Actions
Adnexal Diseases
Spironolactone
Neoplasms
Aldosterone Antagonists

ClinicalTrials.gov processed this record on February 08, 2010