Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males
- Registration Number
- NCT01133548
- Lead Sponsor
- AbbVie
- Brief Summary
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
- Detailed Description
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 62
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Testosterone Gel 1.62% Testosterone Gel 1.62%
- Primary Outcome Measures
Name Time Method Average Plasma Concentration observed (Cav) Up to 24 days Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol
Maximum Plasma Concentration observed (Cmax) Up to 24 days Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol
Area Under the Plasma Concentration-time Curve (AUC) Up to 24 days Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol
Time of Cmax (Tmax) Up to 24 days Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol
- Secondary Outcome Measures
Name Time Method Application site evaluation based on the clinical evaluation of skin reactions grading scale 24 days Adverse events 24 days