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
December 5, 2017 updated by: AbbVie
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.
Study Overview
Detailed Description
Single-center, single dose, open-label study in 12 healthy male and 12 healthy female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria
- BMI between 20-35 kg/m^2 inclusive.
Exclusion Criteria
- Males: history, current or suspected prostate or breast cancer.
- Females: pregnant or lactating.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
5 grams
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Plasma Concentration observed (Cmax)
Time Frame: Up to 5 days
|
Maximum plasma concentration observed (Cmax) of total testosterone
|
Up to 5 days
|
|
Area Under the Plasma Concentration-time Curve (AUC)
Time Frame: Up to 5 days
|
Area under the plasma concentration-time curve (AUC) of total testosterone
|
Up to 5 days
|
|
Average Plasma Concentration observed (Cav)
Time Frame: Up to 5 days
|
Average Plasma Concentration observed (Cav) of total testosterone
|
Up to 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
May 21, 2010
First Submitted That Met QC Criteria
May 25, 2010
First Posted (Estimate)
May 26, 2010
Study Record Updates
Last Update Posted (Actual)
December 7, 2017
Last Update Submitted That Met QC Criteria
December 5, 2017
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S176.1.011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.