Back to resultsA Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application
Primary Purpose
Hypogonadism
Status
Completed
Phase
Locations
Australia
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Hypogonadism focused on measuring Open label, single dose, pharmacokinetic study
Eligibility Criteria
Healthy Male Subjects:
Inclusion:
- Healthy male subjects aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.
Exclusion:
- Men with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.
Healthy Female Subjects:
Inclusion:
- Healthy premenopausal women aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.
Exclusion:
- Women with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.
Sites / Locations
- QPharm
Outcomes
Primary Outcome Measures
Pharmacokinetics
Single dose pharmacokinetic parameters (AUC0-24, AUC0-72, Cmin, Cmax, and tmax) are to be reported for total testosterone, free testosterone and DHT.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01172366
Brief Title
A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application
Official Title
A Phase I Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application of 2% Testosterone Metered Dose (MD) Lotion®
Study Type
Observational
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Acrux DDS Pty Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The hypotheses for this study is that there is no transfer of testosterone from male (donor) subjects to female (recipient) subjects when contact is made 2 hours post application of 2% Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Open label, single dose, pharmacokinetic study
7. Study Design
Enrollment
20 (Anticipated)
Primary Outcome Measure Information:
Title
Pharmacokinetics
Description
Single dose pharmacokinetic parameters (AUC0-24, AUC0-72, Cmin, Cmax, and tmax) are to be reported for total testosterone, free testosterone and DHT.
Time Frame
72 hours total
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy Male Subjects:
Inclusion:
Healthy male subjects aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.
Exclusion:
Men with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.
Healthy Female Subjects:
Inclusion:
Healthy premenopausal women aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.
Exclusion:
Women with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.
Study Population Description
Healthy male and female volunteers
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Soulis, BSc, PhD
Organizational Affiliation
Acrux DDS Pty Ltd
Official's Role
Study Director
Facility Information:
Facility Name
QPharm
City
Brisbane
State/Province
Queensland
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application
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