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 on October 18, 1999. Last Updated on 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:	Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Endocrine Diseases Polycystic Ovary Syndrome

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

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

Acanthosis Nigricans
Insulin Resistance
Polycystic Ovary Syndrome
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Spironolactone
Leuprolide
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on February 09, 2012