NCT01422733

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)

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: Female
• Age: 7 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Hyperandrogenemia
• Obesity
• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Hydrocortisone	10mg/m2/per day PO at bedtime (X12 weeks)
DRUG	dexamethasone	1 mg PO twice
DRUG	Cosyntropin	250 micrograms IV twice
DRUG	rhCG	25 mcg IV twice

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-07-17
• Completion: 2018-07-17
• First posted: 2011-08-24
• Last updated: 2018-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study