Healthy Participants
Conditions
Brief 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.
Interventions
DRUGTestosterone
Administered topically to axillae
OTHERDeodorant Spray
Administered topically to axillae
OTHERDeodorant and Antiperspirant Combination Spray
Administered topically to axillae
OTHERDeodorant and Antiperspirant Combination Stick
Administered topically to axillae
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone | 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 | 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. |
| Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Testosterone 2% Solution Participants randomized to 1 of 4 treatment sequences involving 6 treatments in each sequence. Each sequence involved 4 single-dose treatments of testosterone 2% solution to unshaved axillae with or without the use of deodorant or antiperspirant products followed by 2 single-dose treatments of testosterone 2% solution to shaved axillae with or without the use of deodorant or antiperspirant products. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1 | Withdrawal by Subject | 1 | 0 | 0 | 0 |
| Period 4 | Adverse Event | 0 | 0 | 1 | 0 |
| Washout From Period 3 | Adverse Event | 0 | 1 | 0 | 0 |
| Washout From Period 3 | Protocol Violation | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Testosterone 2% Solution |
|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 7.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native/White | 1 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants |
| Race/Ethnicity, Customized White | 28 participants |
| Region of Enrollment United States | 30 participants |
| Screening Testosterone | 290.8 nanograms per deciliter (ng/dL) STANDARD_DEVIATION 78.2 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 29 | 1 / 29 | 2 / 29 | 4 / 28 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 | 0 / 29 | 0 / 28 | 0 / 26 | 0 / 26 |
Outcome results
Primary
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.
Time frame: 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
Population: All randomized participants who received at least 1 dose of testosterone 2% solution and had evaluable 72-hour testosterone concentrations.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Unshaved | Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone | 2120 nanograms* hours per deciliter (ng*h/dL) | Geometric Coefficient of Variation 164 |
| Testosterone Unshaved + Deodorant Spray | Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone | 2400 nanograms* hours per deciliter (ng*h/dL) | Geometric Coefficient of Variation 196 |
| Testosterone Unshaved + Deodorant Antiperspirant Spray | Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone | 2970 nanograms* hours per deciliter (ng*h/dL) | Geometric Coefficient of Variation 92 |
| Testosterone Unshaved + Deodorant Antiperspirant Stick | Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone | 2880 nanograms* hours per deciliter (ng*h/dL) | Geometric Coefficient of Variation 129 |
| Testosterone Shaved | Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone | 3110 nanograms* hours per deciliter (ng*h/dL) | Geometric Coefficient of Variation 129 |
| Testosterone Shaved + Deodorant Antiperspirant Spray | Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone | 2070 nanograms* hours per deciliter (ng*h/dL) | Geometric Coefficient of Variation 1733 |
Primary
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.
Time frame: 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
Population: All randomized participants who received at least 1 dose of testosterone 2% solution for the specified treatment regimen.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Unshaved | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone | 214 nanograms per deciliter (ng/dL) | Geometric Coefficient of Variation 97 |
| Testosterone Unshaved + Deodorant Spray | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone | 209 nanograms per deciliter (ng/dL) | Geometric Coefficient of Variation 119 |
| Testosterone Unshaved + Deodorant Antiperspirant Spray | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone | 234 nanograms per deciliter (ng/dL) | Geometric Coefficient of Variation 106 |
| Testosterone Unshaved + Deodorant Antiperspirant Stick | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone | 202 nanograms per deciliter (ng/dL) | Geometric Coefficient of Variation 97 |
| Testosterone Shaved | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone | 231 nanograms per deciliter (ng/dL) | Geometric Coefficient of Variation 102 |
| Testosterone Shaved + Deodorant Antiperspirant Spray | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone | 151 nanograms per deciliter (ng/dL) | Geometric Coefficient of Variation 519 |