Clinical Trials Directory

Trials / Completed

CompletedNCT01816295

A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
715 (actual)
Sponsor
Eli Lilly and Company · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGTestosterone SolutionAdministered topically to axillae.
DRUGPlacebo SolutionAdministered topically to axillae.

Timeline

Start date
2013-05-01
Primary completion
2014-10-01
Completion
2015-04-01
First posted
2013-03-22
Last updated
2015-12-28
Results posted
2015-10-02

Locations

85 sites across 9 countries: United States, Argentina, Canada, Germany, Italy, Puerto Rico, South Korea, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT01816295. Inclusion in this directory is not an endorsement.