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

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.

Completed

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Key information

Conditions

Acanthosis Nigricans Adnexal Diseases Cysts Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hyperpigmentation Melanosis Neoplasms Ovarian Cysts Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Polycystic Ovary Syndrome Rare Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

0 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leuprolide Acetate

Drug

Spironolactone

Drug

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

Baylor College of Medicine

Registry information

Important dates

Study start: 1989
Study completion: 1996
First posted: Oct 19, 1999
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed