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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Baylor College of Medicine |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004311 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acanthosis Nigricans Polycystic Ovary Syndrome |
Drug: leuprolide acetate Drug: spironolactone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Study Start Date: | July 1989 |
| Estimated Study Completion Date: | January 1996 |
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
| Study ID Numbers: | 199/11816, BCM-467 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004311 History of Changes |
| Health Authority: | United States: Federal Government |
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acanthosis nigricans dermatologic disorders endocrine disorders polycystic ovarian syndrome rare disease |
|
Gonadal Disorders Hormone Antagonists Diuretics Hormones, Hormone Substitutes, and Hormone Antagonists Hyperandrogenism Ovarian Diseases Hormones Polycystic Ovarian Syndrome Insulin Genital Diseases, Female Hyperinsulinism Leuprolide Melanosis Metabolic Disorder Hyperpigmentation |
Metabolic Diseases Antineoplastic Agents, Hormonal Skin Diseases Pigmentation Disorders Rare Diseases Endocrine System Diseases Cardiovascular Agents Cysts Acanthosis Nigricans Spironolactone Aldosterone Antagonists Polycystic Ovary Syndrome Insulin Resistance Endocrinopathy Glucose Metabolism Disorders |
|
Antineoplastic Agents Gonadal Disorders Hormone Antagonists Physiological Effects of Drugs Diuretics Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Ovarian Diseases Genital Diseases, Female Hyperinsulinism Pathologic Processes Leuprolide Therapeutic Uses Syndrome Melanosis |
Hyperpigmentation Metabolic Diseases Disease Antineoplastic Agents, Hormonal Skin Diseases Pigmentation Disorders Endocrine System Diseases Cardiovascular Agents Cysts Acanthosis Nigricans Pharmacologic Actions Adnexal Diseases Spironolactone Neoplasms Aldosterone Antagonists |
