PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate

Phase 2/3 Completed 62 enrolled University of Washington National Institute on Aging (NIA) · collab National Institutes of Health (NIH) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The investigators will conduct a three-month, randomized, placebo-controlled trial comparing the effects of increasing doses of androgen supplementation with Testosterone (T) gel on the prostate in healthy men who are treated with acyline to block gonadal androgen production.

Timeline

Start: 2011-10
Primary completion: 2014-06
Completion: 2014-12

Publications

Results Thirumalai A, Cooper LA, Rubinow KB, Amory JK, Lin DW, Wright JL, Marck BT, Matsumoto AM, Page ST. Stable Intraprostatic Dihydrotestosterone in Healthy Medically Castrate Men Treated With Exogenous Testosterone. J Clin Endocrinol Metab. 2016 Jul;101(7):2937-44. doi: 10.1210/jc.2016-1483. Epub 2016 May 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Testosterone	Small molecule	1.25 g	Other
Comparator	Testosterone	Small molecule	2.5 g	Other
Comparator	Testosterone	Small molecule	5 g	Other
Comparator	Testosterone	Small molecule	10 g	Other
Comparator	Testosterone	Small molecule	15 g	Other
Comparator	Acyline	Protein / enzyme biologic	300 ug/kg	Subcutaneous

Indications

No indication recorded.