A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application
This study has been completed.
Information provided by:
Acrux DDS Pty Ltd
First received: July 28, 2010
Last updated: September 2, 2010
Last verified: August 2010
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.
||A Phase I Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application of 2% Testosterone Metered Dose (MD) Lotion®
Primary Outcome Measures:
- Pharmacokinetics [ Time Frame: 72 hours total ] [ Designated as safety issue: No ]
Single dose pharmacokinetic parameters (AUC0-24, AUC0-72, Cmin, Cmax, and tmax) are to be reported for total testosterone, free testosterone and DHT.
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2010 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Healthy male and female volunteers
Healthy Male Subjects:
- 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.
- 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:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172366
|Brisbane, Queensland, Australia |
Acrux DDS Pty Ltd
||Tina Soulis, BSc, PhD
||Acrux DDS Pty Ltd
No publications provided
||Director, Clinical Development, Acrux DDS Pty Ltd
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 28, 2010
||September 2, 2010
||United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Keywords provided by Acrux DDS Pty Ltd:
Open label, single dose, pharmacokinetic study
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 01, 2015
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs