CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 13 enrolled
Drug / intervention
Testosterone gel +3 moredrug
Likely dose
Testosterone gel 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00161486
NCT00161486Phase 1Completed
CompareCT.gov

The Effects of Testosterone on Prostate Tissue in Normal Men (ACYP-1)

University of Washington·interventional·Posted Sep 12, 2005·Updated Sep 19, 2008

In Brief

A Phase 1 clinical trial evaluating Testosterone gel, Acyline, and 2 other interventions for Hypogonadism and Contraception. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The purpose of this research study is to understand the effects of testosterone on the prostate. This knowledge will be used to help in the development of a safe male hormonal contraceptive and may impact the development of androgen replacement therapy in older men.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism, Contraception
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartJul 1, 2004
Primary CompletionNov 1, 2004
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 20.8 years ago

Interventions

Testosterone geldrug

Testosterone gel 100 mg daily for 4 weeks

Acylinedrug

Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks

Placebo acylinedrug

Placebo acyline injections every two weeks (2 doses)

Placebo Testosterone geldrug

placebo testosterone gel daily for 4 weeks