Phase 1
N=30
A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT01725451 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone — 2120; 2400; 2970; 2880 nanograms* hours per deciliter (ng*h/dL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Testosterone (Drug); Deodorant Spray (Other); Deodorant and Antiperspirant Combination Spray (Other); Deodorant and Antiperspirant Combination Stick (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone |
2120; 2400; 2970; 2880; 3110; 2070 | — |
| PRIMARY Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone |
214; 209; 234; 202; 231; 151 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01725451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.