Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males

Study Identifier
S176.1.010
CT.gov Identifier
NCT01133548
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Men's Health
    • Study Drug
  • Testosterone Gel 1.62%
    • Phase
    Phase 1
    Sex
    Male
    Age
    18 - 80 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Inclusion Criteria 1. Hypogonadal males 2. Screening testosterone \<300 ng/dL Exclusion Criteria 1. Smokers 2. Previous history of or current or suspected prostate or breast cancer

    Protocol Summary

    To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

    Study Locations

    No locations found.