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:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males|
- Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 ]Cavg criteria was ≥75% of participants with Cavg0-24h ≥300-≤1140 ng/dL and lower limit of 95% confidence interval (CI) ≥65%
- Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 ]Cmax criteria was ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522431
|Study Director:||Liz Waldie||Strakan Pharmaceuticals, Inc.|