To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion
MTE10
A Phase I Trial to Determine the Impact of Application of Antiperspirant and Deodorant as Well as Washing the Application Site, on the Pharmacokinetics of Testosterone Following Single Dose Applications of 2% Testosterone MD-Lotion® (Cutaneous Solution)
1 other identifier
interventional
36
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedOctober 14, 2009
October 1, 2009
1 month
March 5, 2009
October 12, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application.
April 2009
Study Arms (6)
Group 1
ACTIVE COMPARATORGroup 2
ACTIVE COMPARATORGroup 3
ACTIVE COMPARATORGroup 4
ACTIVE COMPARATORGroup 5
ACTIVE COMPARATORGroup 6
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy premenopausal female subjects ≥18 and ≤45 years of age with qualifying general medical health.
You may not qualify if:
- Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
QPharm Pty Ltd
Brisbane, Queensland, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tina Soulis, PhD
Acrux Pharma Pty Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
January 1, 2009
Primary Completion
February 1, 2009
Study Completion
April 1, 2009
Last Updated
October 14, 2009
Record last verified: 2009-10