Clinical Trials Directory

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UnknownNCT01786473

Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism

A Multi-center, Double Blind, Randomized, Placebo Controlled Study of Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
240 (estimated)
Sponsor
Laboratoires Besins International · Industry
Sex
Male
Age
18 Years – 68 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel administered once daily (QD, morning dosing) compared to placebo administered once daily (QD, morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being confirmed by clinical features and biochemical tests. For men with hypogonadism, treatment aims to restore testosterone levels to normal physiological range.

Conditions

Interventions

TypeNameDescription
DRUGTestogel 1%
DRUGPlacebo

Timeline

Start date
2012-12-01
Primary completion
2014-12-01
First posted
2013-02-08
Last updated
2013-02-08

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01786473. Inclusion in this directory is not an endorsement.