Clinical Trial: Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS003)
Brief Summary: Short term hydrocortisone to test whether improves excess androgen production from adrenal gland and ovaries
Detailed Summary: This study will test whether short-term suppression of adrenal function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one month of 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 adrenocorticotropin hormone (ACTH).
Sponsor: University of Virginia
Current Primary Outcome: Changes in free testosterone after ACTH administration before and after hydrocortisone administration for 4 weeks [ Time Frame: 30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration ]
Original Primary Outcome: Changes in free testosterone after ACTH administration before and after hydrocortisone administration for 4 weeks [ Time Frame: 30 and 60 minutes after ACTH, baseline and after 4 weeks of hydrocortisone administration ]
Current Secondary Outcome: Changes in adrenal steroid precursors after ACTH, baseline, and after 4 weeks of hydrocortisone administration [ Time Frame: 30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration ]
Original Secondary Outcome: Changes in adrenal steroid precursors after ACTH, baseline and after 4 weeks of hydrocortisone administration [ Time Frame: 30 and 60 minutes after ACTH, baseline and after 4 weeks of hydrocortisone administration ]
Information By: University of Virginia
Dates:
Date Received: August 19, 2011
Date Started: April 2017
Date Completion: June 2018
Last Updated: December 16, 2016
Last Verified: December 2016