drugset / Trial / NCT01422733

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

NCT01422733

Phase 0 Withdrawn University of Virginia
NaSingle-groupOpen-labelBasic science

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).

Timeline

Start
2018-06-01
Primary completion
2018-07-17
Completion
2018-07-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortisone Other / unclassified 10 mg/m2 Oral
Background Cosyntropin Unknown 250 ug Intravenous
Background Dexamethasone Small molecule 1 mg Oral
Background rhCG Unknown 25 ug Intravenous