At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dose Response Effects of Exogenous Testosterone on the Prostate and Comparison With Effects on Body Composition (Short Title: PROS-2)
In Brief
A Phase 3 clinical trial evaluating placebo acyline, placebo gel, and 6 other interventions for Healthy. Completed, enrolled 62 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Placebo acyline subcutaneous injection every 2 weeks
daily placebo testosterone gel applied transdermally x 12 weeks
testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks
Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks
Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks
Testosterone 1% gel 10 g daily applied transdermally x 12 weeks
Testosterone 1% gel 15 g daily applied transdermally x 12 weeks
300 ug/kg subcutaneous injection every 2 weeks