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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00857168




Registration number
NCT00857168
Ethics application status
Date submitted
5/03/2009
Date registered
6/03/2009
Date last updated
14/10/2009

Titles & IDs
Public title
To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion
Scientific title
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)
Secondary ID [1] 0 0
MTE10
Universal Trial Number (UTN)
Trial acronym
MTE10
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypogonadism 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Group 1 -

Active comparator: Group 2 -

Active comparator: Group 3 -

Active comparator: Group 4 -

Active comparator: Group 5 -

Active comparator: Group 6 -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
April 2009
Secondary outcome [1] 0 0
To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application.
Timepoint [1] 0 0
April 2009

Eligibility
Key inclusion criteria
* Healthy premenopausal female subjects =18 and =45 years of age with qualifying general medical health.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
QPharm Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Acrux DDS Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tina Soulis, PhD
Address 0 0
Acrux Pharma Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00857168