Conditions: Hypogonadism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 715
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Placebo Solution applied topically once daily for 12 weeks. arm 2: Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks.

Interventions: intervention 1: Testosterone Solution intervention 2: Placebo Solution
Intervention descriptions: intervention 1: Administered topically to axillae. intervention 2: Administered topically to axillae.

Protocol document: