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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00857168 |
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Date of registration:
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05/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion
MTE10 |
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Scientific title:
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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) |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00857168 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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Contacts
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Name:
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Tina Soulis, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Acrux Pharma Pty Ltd |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hypogonadism
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Intervention(s)
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Drug: Testosterone MD-Lotion
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Primary Outcome(s)
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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.
[Time Frame: April 2009]
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Secondary Outcome(s)
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To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application.
[Time Frame: April 2009]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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