A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Deodorant and Antiperspirant Use and the Presence of Axillary Hair on the Absorption of Testosterone Applied as Testosterone 2% Solution

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Testosterone
* Other: Deodorant Spray
* Other: Deodorant and Antiperspirant Combination Spray
* Other: Deodorant and Antiperspirant Combination Stick


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone Unshaved<br>No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods. | Drug: Testosterone<br>* Administered topically to axillae<br>* Other names: LY900011;|
| Experimental: Testosterone Unshaved + Deodorant Spray<br>Deodorant spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. | Drug: Testosterone<br>* Administered topically to axillae<br>* Other names: LY900011;Other: Deodorant Spray<br>* Administered topically to axillae<br>|
| Experimental: Testosterone Unshaved + Deodorant Antiperspirant Spray<br>Deodorant antiperspirant combination spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. | Drug: Testosterone<br>* Administered topically to axillae<br>* Other names: LY900011;Other: Deodorant and Antiperspirant Combination Spray<br>* Administered topically to axillae<br>|
| Experimental: Testosterone Unshaved + Deodorant Antiperspirant Stick<br>Deodorant antiperspirant combination stick applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. | Drug: Testosterone<br>* Administered topically to axillae<br>* Other names: LY900011;Other: Deodorant and Antiperspirant Combination Stick<br>* Administered topically to axillae<br>|
| Experimental: Testosterone Shaved<br>No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods. | Drug: Testosterone<br>* Administered topically to axillae<br>* Other names: LY900011;|
| Experimental: Testosterone Shaved + Deodorant Antiperspirant Spray<br>Deodorant antiperspirant combination spray applied to shaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods. | Drug: Testosterone<br>* Administered topically to axillae<br>* Other names: LY900011;Other: Deodorant and Antiperspirant Combination Spray<br>* Administered topically to axillae<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone | The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations. | Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug | 
| Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone | The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations. | Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug |