A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants
Condition: Healthy Participants
Intervention: Testosterone; Deodorant Spray; Deodorant and Antiperspirant Combination Spray; Deodorant and Antiperspirant Combination Stick
Intervention description: Administered topically to axillae; Administered topically to axillae; Administered topically to axillae; Administered topically to axillae
Intervention MeSH terms: Testosterone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the effect of deodorant and antiperspirant use and the presence of
      underarm hair on the absorption of testosterone. Each participant in this study will receive
      6 single doses of 30 milligrams (mg) testosterone applied as a solution to each underarm.
      There is a minimum one day washout period between each dose. This study will last
      approximately 24 days not including screening. Screening is required within 30 days prior to
      the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males, as determined by medical history and physical examination

          -  Agree to use a reliable method of birth control (for example, condom or vasectomy)
             during the study and for 1 month following the last dose of testosterone

          -  Have a total testosterone level <400 nanograms per deciliter (ng/dL) based on local
             laboratory result

          -  Have a hemoglobin ≥12 grams per deciliter (g/dL) at screening and, if the participant
             takes a break from the study, at the re-test

          -  Weigh at least 60 kilograms (kg)

          -  Have venous access sufficient to allow for blood sampling

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures

          -  Have given written informed consent approved by Eli Lilly and Company (Lilly) and the
             ethical review board (ERB) governing the site

        Exclusion Criteria:

          -  Use any topical testosterone replacement therapy within the 2 weeks prior to
             randomization through the last dosing period, except for use of testosterone solution
             as directed by study procedures

          -  Use parenteral testosterone replacement (testosterone enanthanate, testosterone
             cypionate) within the 30 days prior to screening. Use long-acting intramuscular
             testosterone undecanoate 6 months prior to screening, or use of testosterone pellets
             12 months prior to screening

          -  Have a body mass index >35 kilograms per square meter (kg/m^2)

          -  Have a significant history of allergy and/or sensitivity to the drug products or
             excipients, including any history of sensitivity to testosterone

          -  Currently use any medications, herbal, and/or nutritional supplements that can
             interfere with testosterone

          -  Have a dermatologic condition in the underarm area that might interfere with
             testosterone absorption (for example, eczema) or be exacerbated by topical
             testosterone replacement therapy

          -  Have a history or presence of/significant history of or current cardiovascular,
             respiratory, hepatic, renal, endocrine, hematological, or neurological disorders
             constituting a risk when taking the study medication of that could interfere with the
             interpretation of the data

          -  Have had lymphoma, leukemia, or any malignancy within the past 5 years except for
             basal cell or squamous epithelial carcinomas of the skin that have been resected with
             no evidence of metastatic disease for 3 years

          -  Have an abnormal prostate-specific antigen (PSA) test result

          -  Have known allergies to testosterone solution, related compounds or any components of
             the formulation, or history of significant atopy

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Have an abnormal blood pressure as determined by the investigator

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Show evidence of hepatitis B and/or positive hepatitis B surface antigen

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody

          -  Show evidence of human immunodeficiency (HIV) infection and/or positive human HIV
             antibodies

          -  Are participants who have previously completed or withdrawn from this study or any
             other study investigating testosterone

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an investigational product or nonapproved use of a drug or device
             (other than the investigational product used in this study), or are concurrently
             enrolled in any other type of medical research judged not to be scientifically or
             medically compatible with this study

          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
             study

          -  Have shaved the axillae within 3 months of screening