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A Multi-Center, Randomized, Double-Blind,Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of Hypogonadal Men
Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men
Details
| Lead sponsor | Abbott |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 274 |
| Start date | 2007-02 |
| Completion | 2008-04 |
Conditions
- Hypogonadism
Interventions
- Testosterone (T) Gel 1.62%
- Placebo
Primary outcomes
- Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112 — Day 112
Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as \>=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results