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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004311
Enrollment
Unknown
Registered
1999-10-19
Start date
1989-07-31
Completion date
1996-01-31
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acanthosis Nigricans, Polycystic Ovary Syndrome

Keywords

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

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.

Interventions

DRUGleuprolide acetate
DRUGspironolactone

Sponsors

Baylor College of Medicine
CollaboratorOTHER
National Center for Research Resources (NCRR)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Age
0 Years to No maximum
Healthy volunteers
No

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026