Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
274
Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.
Placebo Control
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
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
Time frame: Day 112
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14
Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success 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 14 PK results
Time frame: Day 14
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56
Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success 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 56 PK results
Time frame: Day 56
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182
Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success 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 182 PK results.
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Time frame: Day 182
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.
The success at Day 266 was defined as \>=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
Time frame: Day 266
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.
The success at Day 364 was defined as \>=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
Time frame: Day 364