- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01172366
A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application
September 2, 2010 updated by: Acrux DDS Pty Ltd
A Phase I Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application of 2% Testosterone Metered Dose (MD) Lotion®
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Queensland
-
Brisbane, Queensland, Australia
- QPharm
-
-
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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy male and female volunteers
Description
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 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?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics
Time Frame: 72 hours total
|
Single dose pharmacokinetic parameters (AUC0-24, AUC0-72, Cmin, Cmax, and tmax) are to be reported for total testosterone, free testosterone and DHT.
|
72 hours total
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tina Soulis, BSc, PhD, Acrux DDS Pty Ltd
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
August 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
July 28, 2010
First Submitted That Met QC Criteria
July 28, 2010
First Posted (Estimate)
July 29, 2010
Study Record Updates
Last Update Posted (Estimate)
September 6, 2010
Last Update Submitted That Met QC Criteria
September 2, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTE12
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.
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