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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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At 0800h to 0900h, a 25 mm plastic intravenous line will be inserted in an antecubital vein. Then, 1 μg/ml ACTH aliquot stock solution will be pushed through, followed by 5 ml physiologic saline (0.9%). Serum cortisol and salivary free cortisol will measured just before ACTH administration and 30 minutes later.

Cosyntropin stimulation test

Leonard Saiegh, MD

Leonard Saiegh

Michal Yeiches

In mitotane treated patients, serum cortisol cannot be used to diagnose hypoadrenalism, since mitotane increases cortisol binding globulin levels (CBG), artificially raising total cortisol. Salivary free cortisol (SC) is not affected by CBG alterations, and reflects the free serum cortisol.

In the current study, investigators will assess serum and SC responses during low-dose cosyntropin stimulation test in healthy volunteers, mitotane-induced hypoadrenal patients on steroid replacement therapy and in patients who suffer from hypoadrenlism caused from other etiology. Investigators will compare results between groups and try to demonstrate the superiority of SC in assessing adrenal function in mitotane treated patients.

80-90% of circulating cortisol is bound to cortisol binding globulin (CBG) or transcortin, whereas only 3-10% is in the free state. Salivary free cortisol (SC) is an index of plasma free cortisol. In previous studies it was shown that in low-dose cosyntropin stimulation test, SC increases significantly in normal but not in hypoadrenal patients. It was suggested that dynamic assessment of the SC response to ACTH may be particularly helpful whenever the measurement of serum cortisol is complicated by increased or decreased CBG levels.

Adrenocortical carcinoma (ACC) is a rare malignancy with a heterogeneous presentation and a variable but generally poor prognosis. Mitotane is the main drug for ACC treatment and it plays a role both in adjuvant treatment after complete resection and in recurrent, inoperable and/or metastatic ACC. Mitotane blocks adrenocortical steroid synthesis and also exerts a specific cytotoxic effect on adrenocortical cells. Mitotane induces adrenal insufficiency, requiring hydrocortisone replacement therapy. In mitotane treated patients, serum cortisol cannot be used to diagnose hypoadrenalism, since mitotane increases CBG levels, artificially raising total cortisol. SC is not affected by CBG alterations, and reflects the free serum cortisol and may be more accurate in diagnosing hypoadrenalism in mitotane treated patients.

In the current study, investigators will assess serum and SC responses during low-dose cosyntropin stimulation test in healthy volunteers, mitotane-induced hypoadrenal patients on steroid replacement therapy and in patients who suffer from hypoadrenlism caused from any other etiology. Investigators will compare results between groups and try to demonstrate the superiority of SC in assessing adrenal function in mitotane treated patients.

Salivary Free Cortisol Response to Cosyntropin Stimulation Test in Mitotane Treated Patients

Salivary free cortisol concentrations during intravenous low dose cosyntropin stimulation test..

Serum cortisol concentrations during intravenous low dose cosyntropin stimulation test.

Bnai Zion Medical Center

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
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
Salivary Free Cortisol Response to Cosyntropin Stimulation Test in Mitotane Treated Patients	NCT03083834	Adrenal Insuffi... Adrenal Cancer	Cosyntropin sti...	18 Years - 80 Years	Bnai Zion Medical Center

Spots Global Cancer Trial Database for cosyntropin

Every month we try and update this database with for cosyntropin 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 cosyntropin

Every month we try and update this database with for cosyntropin 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 cosyntropin 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.