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Polycystic Ovary Syndrome

Insulin Resistance

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Hyperandrogenism

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Mineralocorticoids

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Diuretics, Potassium Sparing

leuprolide acetate

spironolactone

Karen E. Elkind-Hirsch

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.

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

Baylor College of Medicine

National Center for Research Resources (NCRR)

Nervous System Diseases

Musculoskeletal Diseases

Obesity

Adenoma

Pituitary Diseases

Cushing Syndrome

Acromegaly

Hypopituitarism

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Bone Diseases

Bone Diseases, Endocrine

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Adrenocortical Hyperfunction

Adrenal Gland Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Cushing's Syndrome

Hyperadrenalism

The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies, and to evaluate the potential beneficial effect of surgical and medical treatments with agonists and antagonists of hypothalamic neuropeptides, currently available, on the development and treatment of adiposity and negative cross-talk between adiposity and muscle/bone tissue

Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models

The study aims to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies

IRCCS San Raffaele

Professor of Endocrinology and Metabolism

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Anticoagulants

Other Dietary Supplements

Metformin

Citric Acid

Sodium Citrate

Clomiphene

Enclomiphene

Zuclomiphene

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Citrate

clomiphene citrate

metformin

William S. Evans

OBJECTIVES:

I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms.

Patients receive oral metformin or oral placebo three times daily for 7 weeks. Patients remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110. Following ovulation, treatment with clomiphene citrate and metformin or placebo continues until 6 ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients receiving the placebo arm who have not ovulated on the highest dose of clomiphene citrate may be crossed over to receive metformin after a 6 week washout.

Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome

University of Virginia

OBJECTIVES:

I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms.

Patients receive oral metformin (arm I) or oral placebo (arm II) three times daily for 8 weeks. All patients who do not ovulate by day 28 receive oral clomiphene citrate daily on days 36-40.

Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT00004311	Acanthosis Nigr... Polycystic Ovar...	leuprolide acet... spironolactone	0 Years -	Office of Rare Diseases (ORD)
Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models	NCT06326853	Endocrine Disor... Adiposity Pituitary Adeno... Cushing Syndrom... Acromegaly Hypopituitarism		18 Years -	IRCCS San Raffaele
Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome	NCT00005104	Polycystic Ovar... Hyperinsulinism	clomiphene citr... metformin	18 Years - 40 Years	National Center for Research Resources (NCRR)
Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome	NCT00005104	Polycystic Ovar... Hyperinsulinism	clomiphene citr... metformin	18 Years - 40 Years	National Center for Research Resources (NCRR)
Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome	NCT00005104	Polycystic Ovar... Hyperinsulinism	clomiphene citr... metformin	18 Years - 40 Years	National Center for Research Resources (NCRR)
Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome	NCT00005654	Hyperinsulinism Polycystic Ovar...	clomiphene citr... metformin	18 Years - 40 Years	Office of Rare Diseases (ORD)

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