Back to resultsPharmacokinetic 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
Primary Purpose
Hypogonadism
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Testosterone Gel 1.62%
Testosterone Gel 1.62%
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring testosterone, hypogonadal, males
Eligibility Criteria
Inclusion Criteria
- Hypogonadal males
- Screening testosterone <300 ng/dL
Exclusion Criteria
- Smokers
- Previous history of or current or suspected prostate or breast cancer
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Testosterone Gel 1.62%
Outcomes
Primary Outcome Measures
Maximum Plasma Concentration observed (Cmax)
Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol
Area Under the Plasma Concentration-time Curve (AUC)
Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol
Time of Cmax (Tmax)
Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol
Average Plasma Concentration observed (Cav)
Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol
Secondary Outcome Measures
Application site evaluation based on the clinical evaluation of skin reactions grading scale
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01133548
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
testosterone, hypogonadal, males
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Testosterone Gel 1.62%
Intervention Type
Drug
Intervention Name(s)
Testosterone Gel 1.62%
Intervention Description
5 grams administered using an application Site Rotation
Intervention Type
Drug
Intervention Name(s)
Testosterone Gel 1.62%
Intervention Description
5 grams administered using an a combination of Application sites
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration observed (Cmax)
Description
Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol
Time Frame
Up to 24 days
Title
Area Under the Plasma Concentration-time Curve (AUC)
Description
Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol
Time Frame
Up to 24 days
Title
Time of Cmax (Tmax)
Description
Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol
Time Frame
Up to 24 days
Title
Average Plasma Concentration observed (Cav)
Description
Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol
Time Frame
Up to 24 days
Secondary Outcome Measure Information:
Title
Application site evaluation based on the clinical evaluation of skin reactions grading scale
Time Frame
24 days
Title
Adverse events
Time Frame
24 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Hypogonadal males
Screening testosterone <300 ng/dL
Exclusion Criteria
Smokers
Previous history of or current or suspected prostate or breast cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael miller, PharmD
Organizational Affiliation
Abbott
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21492400
Citation
Kaufman JM, Miller MG, Garwin JL, Fitzpatrick S, McWhirter C, Brennan JJ. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med. 2011 Jul;8(7):2079-89. doi: 10.1111/j.1743-6109.2011.02265.x. Epub 2011 Apr 14.
Results Reference
result
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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
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