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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

Primary Purpose

Acanthosis Nigricans, Polycystic Ovary Syndrome

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

leuprolide acetate

spironolactone

About this trial

This is an interventional treatment trial for Acanthosis Nigricans focused on measuring acanthosis nigricans, dermatologic disorders, endocrine disorders, polycystic ovarian syndrome, rare disease

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004311

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Baylor College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00004311

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2000

Overall Recruitment Status

Completed

Study Start Date

July 1989 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 1996 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Baylor College of Medicine

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acanthosis Nigricans, Polycystic Ovary Syndrome

Keywords

acanthosis nigricans, dermatologic disorders, endocrine disorders, polycystic ovarian syndrome, rare disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

leuprolide acetate

Intervention Type

Drug

Intervention Name(s)

spironolactone

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

0 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen E. Elkind-Hirsch

Organizational Affiliation

Baylor College of Medicine

Official's Role

Study Chair

12. IPD Sharing Statement

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