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NCT00004311 Clinical Trial

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

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004311
Other study ID # 199/11816
Secondary ID BCM-467
Status Completed
Phase Phase 2
First received October 18, 1999
Last updated June 23, 2005
Start date July 1989
Est. completion date January 1996

Study information
Verified date May 2000
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date January 1996
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• leuprolide acetate

• spironolactone

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Baylor College of Medicine
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