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| ID | Type | Description | Link |
|---|---|---|---|
| BCM-467 |
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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leuprolide acetate | Drug | |||
| spironolactone | Drug |
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
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| Name | Affiliation | Role |
|---|---|---|
| Karen E. Elkind-Hirsch | Baylor College of Medicine | Study Chair |
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| ID | Term |
|---|---|
| D000052 | Acanthosis Nigricans |
| D011085 | Polycystic Ovary Syndrome |
| D012871 | Skin Diseases |
| D004700 | Endocrine System Diseases |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D017437 | Skin and Connective Tissue Diseases |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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