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12 weeks hydrocortisone, dexamethasone, and Cosyntropin (ACTH) to perform standardized adrenal stimulation testing; dexamethasone, and rhCG to perform standardized ovarian stimulation testing

10mg/m2/per day PO at bedtime (X12 weeks)

dexamethasone

rhCG

Christine Burt Solorzano, MD

This study will test whether longer-term suppression of adrenal function can ameliorate androgen (male hormone) overproduction in overweight early pubertal girls with androgen excess. The investigators hypothesize that suppression of nighttime adrenocorticotropin hormone (ACTH) production by 12 weeks of evening oral hydrocortisone administration will improve androgen levels in girls with adrenal androgen overproduction. Specifically, this intervention will improve androgen levels after adrenal stimulation testing with ACTH or ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).

Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction

Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction in Overweight Early Pubertal Girls With Androgen Excess (CBS0004)

University of Virginia

Assistant Professor of Pediatrics

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46, XX Disorders of Sex Development

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Urogenital Abnormalities

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Male Urogenital Diseases

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21-hydroxylase Deficiency

ACTH (Cosyntropin) administered 250 mcg IV; rhCG (Ovidrel) administered 250 mcg IV

ACTH (Cosyntropin) 250 mcg will be given once during the study.

ACTH

rhCG (Ovidrel) 250 mcg will be given once during the study.

Melissa G Gilrain, BS

Melissa Gilrain, BS

Chris McCartney, MD

The objective of the study is to determine the relative contributions of four established predictors of hyperandrogenism (luteinizing hormone \[LH\] secretion, ovarian response to recombinant human chorionic gonadotropin \[r-hCG\] administration, adrenal response to adrenocorticotropic hormone \[ACTH\] administration, and hyperinsulinemia) in older vs. young women with Polycystic Ovary Syndrome (PCOS) in a cross-sectional, physiological study. The investigators hypothesize that hyperinsulinemia is a stronger independent predictor of free testosterone (T) in older reproductive aged (vs. young) women with PCOS.

PCOS is a highly prevalent reproductive disorder characterized by hyperandrogenism (HA) and oligo/anovulation. PCOS is also associated with metabolic syndrome, obesity and insulin resistance. In young women with PCOS, several factors contribute to HA: a) excess LH secretion, b) abnormal ovarian steroidogenesis, c) abnormal adrenal steroidogenesis, and d) hyperinsulinemia/ insulin resistance. Of interest, HA (and menstrual function) improves with age in PCOS. However, the relative contributions of the aforementioned HA-related factors in young adult vs. late reproductive-aged women with PCOS are not known. Identifying the most important predictor(s) of HA in older women with PCOS will be critically important for devising the most relevant therapeutic strategies for older women with PCOS. The investigators propose to determine the relative contributions of four established predictors of HA (LH secretion, ovarian response to r-hCG administration, adrenal response to ACTH administration, and hyperinsulinemia) in older vs. young women with PCOS in a physiological study. The investigators hypothesize that hyperinsulinemia is a stronger independent predictor of free testosterone (T) in older reproductive aged (vs. young) women with PCOS. In addition, the investigators hypothesize that, in older vs. young women with PCOS: a) ovarian response to r-hCG will be a weaker independent predictor of free T; b) mean LH will be a stronger independent predictor of free T; and c) the predictive ability of adrenal response to ACTH will be similar. This will be a cross-sectional physiological study. Ordinary Least Square (OLS) regression will be utilized to determine the relative contributions of 4 established predictors of HA in older vs. young women with PCOS. Statistical plans include intra-age group hypothesis testing, inter-age group hypothesis testing, and a ranking of the importance of predictors in each age group.

This is a cross-sectional physiological observational study.

This is a study regarding PCOS, so only females will be eligible.

Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS

It is an index calculated by using glucose and insulin levels

Professor of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction	NCT01422733	Hyperandrogenem... Obesity Polycystic Ovar...	Hydrocortisone dexamethasone Cosyntropin rhCG	7 Years - 16 Years	University of Virginia
Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS	NCT03905603	Polycystic Ovar...	ACTH rhCG	20 Years - 49 Years	University of Virginia
Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction	NCT01422733	Hyperandrogenem... Obesity Polycystic Ovar...	Hydrocortisone dexamethasone Cosyntropin rhCG	7 Years - 16 Years	University of Virginia

Spots Global Cancer Trial Database for rhcg

Every month we try and update this database with for rhcg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rhcg

Every month we try and update this database with for rhcg cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rhcg cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.