Clinical Trials Logo
  1. Home
  2. Polycystic Ovary Syndrome
  3. NCT00004311
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT03142633 - MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Completed NCT06158932 - A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04932070 - Berberine and Polycystic Ovary Syndrome N/A
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT03480022 - Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS Phase 3
Active, not recruiting NCT03043924 - Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT05246306 - Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
Completed NCT05981742 - Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS Phase 2
Completed NCT05702957 - Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome Phase 2/Phase 3
Completed NCT05029492 - Effect of Visceral Manipulation on PCOS N/A
Not yet recruiting NCT02255578 - Endobarrier Treatment in Women With PCOS Phase 3
Completed NCT02924025 - Motivational Interviewing as an Intervention for PCOS N/A
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
Completed NCT02098668 - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON N/A
Withdrawn NCT01638988 - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin Phase 3
Completed NCT01462864 - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome N/A
Recruiting NCT01431352 - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT00989781 - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome N/A