A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.
The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males|
- The primary objective of this study is to replace testosterone in hypogonadal males so that the time averaged serum total testosterone (Cavg) on day 90 lies within specific limits within a pre-specified percentage of patients. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- To replace testosterone in hypogonadal males so that the maximum serum total testosterone (Cmax) on day 90 lies within specific limits. To determine the safety of Fortigel testosterone gel 2.0% in hypogonadal males. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
2% testosterone gel
Other Name: Fortigel