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
Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acanthosis Nigricans; Polycystic Ovary Syndrome
Intervention: leuprolide acetate (Drug); spironolactone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s): Karen E. Elkind-Hirsch, Study Chair, Affiliation: Baylor College of Medicine
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.
Clinical Details
Study design: Primary Purpose: Treatment
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: July 1989
Last updated: June 23, 2005
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