Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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 pharmacokinetics of testosterone MD-Lotion formulations.The study will also assess safety of the product.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Any significant history of allergy and/or sensitivity to the drug products or their excipients, including any history of sensitivity to testosterone and/or sunscreens
Any clinically significant chronic illness or finding on screening physical exam and/or laboratory testing
Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal drug absorption
Men with suspected reversible hypoandrogenism (i.e. due to medications, stress)
Any man in whom testosterone therapy is contraindicated, which included those with:
Men with clinically significant prostate exam or clinically significant elevated serum prostate specific antigen (PSA) level, or age adjusted reference range of PSA values.
Current history of drug or alcohol abuse (more than 4 standard drinks per day and/or abnormal liver function tests 3 times the upper limit of the normal range values)
Men taking concomitant medications that affect sex hormone binding globulin (SHBG) or testosterone concentrations or metabolism, or that were cytochrome P450 inducers or inhibitors, anti-coagulants (warfarin), or diabetic medications (insulin), anti-histamines
Men involved in sport in which there was screening for anabolic steroids
Men with uncontrolled diabetes (hemoglobin A1c [HbA1c] greater than or equal to 10%)
Men taking any Investigational Product, or who had received an Investigational Product within 28 days prior to screening or 5 half-lives (whichever was the longer)
Any contraindication to blood sampling
Study participants who planned to have a surgical procedure during the course of the study
Study participants with a partner of child bearing potential who was not willing to use adequate contraception (i.e. condoms) for the duration of the study
Study participants whose partners were pregnant
Primary purpose
Allocation
Interventional model
Masking
21 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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