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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multiple Dose Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption 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 in Hypogonadal Males

Conditions
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Hypogonadism

Intervention / Treatment
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* Drug: Testosterone Gel 1.62%
* Drug: Testosterone Gel 1.62%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Hypogonadal males Screening testosterone <300 ng/dL Exclusion Criteria Smokers Previous history of or current or suspected prostate or breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Testosterone Gel 1.62% | Drug: Testosterone Gel 1.62%<br>* 5 grams administered using an application Site Rotation<br>Drug: Testosterone Gel 1.62%<br>* 5 grams administered using an a combination of Application sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration observed (Cmax) | Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol | Up to 24 days | 
| Area Under the Plasma Concentration-time Curve (AUC) | Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol | Up to 24 days | 
| Time of Cmax (Tmax) | Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol | Up to 24 days | 
| Average Plasma Concentration observed (Cav) | Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol | Up to 24 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Application site evaluation based on the clinical evaluation of skin reactions grading scale |  | 24 days | 
| Adverse events |  | 24 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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testosterone, hypogonadal, males