To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion
- Registration Number
- NCT00857168
- Lead Sponsor
- Acrux DDS Pty Ltd
- Brief Summary
Testosterone replacement treatment is the most effective way of treating hypogonadism in men.
Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).
The study also aim to evaluate the impact of washing the application site on the absorption of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous solution).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 36
Inclusion Criteria
- Healthy premenopausal female subjects ≥18 and ≤45 years of age with qualifying general medical health.
Exclusion Criteria
- Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Testosterone MD-Lotion - Group 2 Testosterone MD-Lotion - Group 3 Testosterone MD-Lotion - Group 4 Testosterone MD-Lotion - Group 5 Testosterone MD-Lotion - Group 6 Testosterone MD-Lotion -
- Primary Outcome Measures
Name Time Method To evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution). Also to evaluate the impact of washing. April 2009
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application. April 2009
Trial Locations
- Locations (1)
QPharm Pty Ltd
🇦🇺Brisbane, Queensland, Australia