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

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01133548
• Collaborator: (none)
• Enrollment: 62
• Arm: 1
• Duration (Months): 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism	Drug: Testosterone Gel 1.62%; Drug: Testosterone Gel 1.62%	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Testosterone Gel 1.62%	Drug: Testosterone Gel 1.62%; 5 grams administered using an application Site Rotation; Drug: Testosterone Gel 1.62%; 5 grams administered using an a combination of Application sites

Outcome Measures

Primary Outcome Measures

1. Maximum Plasma Concentration observed (Cmax) [Up to 24 days]

   Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol

2. 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

3. Time of Cmax (Tmax) [Up to 24 days]

   Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol

4. Average Plasma Concentration observed (Cav) [Up to 24 days]

   Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol

Secondary Outcome Measures

1. Application site evaluation based on the clinical evaluation of skin reactions grading scale [24 days]

2. Adverse events [24 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. Hypogonadal males

2. Screening testosterone <300 ng/dL

Exclusion Criteria

1. Smokers

2. Previous history of or current or suspected prostate or breast cancer

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Michael miller, PharmD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT01133548
• Other Study ID Numbers: S176.1.010
• First Posted: May 31, 2010
• Last Update Posted: Dec 7, 2017
• Last Verified: Jun 1, 2011

• Keywords provided by AbbVie: testosterone, hypogonadal, males
• Additional relevant MeSH terms: Hypogonadism; Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate

Study Results

No Results Posted as of Dec 7, 2017