An Open-Label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% Applied to the Upper Arms and Shoulders and Use of a T-shirt Barrier
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
Single-center, single dose, open-label study in healthy male and female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started May 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 21, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedDecember 7, 2017
June 1, 2011
Same day
May 21, 2010
December 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum Plasma Concentration observed (Cmax)
Maximum plasma concentration observed (Cmax) of total testosterone
Up to 5 days
Area Under the Plasma Concentration-time Curve (AUC)
Area under the plasma concentration-time curve (AUC) of total testosterone
Up to 5 days
Average Plasma Concentration observed (Cav)
Average Plasma Concentration observed (Cav) of total testosterone
Up to 5 days
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- BMI between 20-35 kg/m\^2 inclusive.
You may not qualify if:
- Males: history, current or suspected prostate or breast cancer.
- Females: pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Related Publications (1)
Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption. Curr Med Res Opin. 2012 Feb;28(2):291-301. doi: 10.1185/03007995.2011.652732. Epub 2012 Jan 24.
PMID: 22188558RESULT
Study Officials
- STUDY DIRECTOR
Michael Miller, PharmD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2010
First Posted
May 26, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
December 7, 2017
Record last verified: 2011-06