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

NCT00004311 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

  • Acanthosis Nigricans
  • Polycystic Ovary Syndrome

Interventions

DRUG

leuprolide acetate

DRUG

spironolactone

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER
  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Karen E. Elkind-Hirsch · Baylor College of Medicine

Study Design

Purpose
TREATMENT

Eligibility

Min Age
0 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1989-07-31
Completion
1996-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004311 on ClinicalTrials.gov