CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 715 enrolled
Drug / intervention
Testosterone Solution +1 moredrug
Likely dose
Not stated in 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/NCT01816295
NCT01816295Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled Parallel Study With an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men

Eli Lilly and Company·interventional·Posted Mar 22, 2013·Updated Dec 28, 2015

In Brief

A Phase 3 clinical trial evaluating Testosterone Solution and Placebo Solution for Hypogonadism. Completed, enrolled 715 participants across 85 sites in 9 countries.

Detailed Summary

The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogonadism
CountriesArgentina, Canada, Germany, Italy, Puerto Rico, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2013
Enrollment StartMay 1, 2013
Primary CompletionOct 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.3 years ago

Interventions

Testosterone Solutiondrug

Administered topically to axillae.

Placebo Solutiondrug

Administered topically to axillae.