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
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
1 other identifier
interventional
62
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2010
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 21, 2010
CompletedFirst Posted
Study publicly available on registry
May 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedDecember 7, 2017
June 1, 2011
2 months
May 21, 2010
December 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Application site evaluation based on the clinical evaluation of skin reactions grading scale
24 days
Adverse events
24 days
Study Arms (1)
1
EXPERIMENTALTestosterone Gel 1.62%
Interventions
Eligibility Criteria
You may qualify if:
- Hypogonadal males
- Screening testosterone \<300 ng/dL
You may not qualify if:
- Smokers
- Previous history of or current or suspected prostate or breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Related Publications (1)
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.
PMID: 21492400RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael miller, PharmD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2010
First Posted
May 31, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
December 7, 2017
Record last verified: 2011-06