A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01725451
First received: November 8, 2012
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: Testosterone Other: Deodorant Spray Other: Deodorant Stick Other: Deodorant and Antiperspirant Combination Stick |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Effects of Deodorant and Antiperspirant Use and the Presence of Axillary Hair on the Absorption of Testosterone Applied as Testosterone 2% Solution |
Resource links provided by NLM:
Drug Information available for:
Testosterone propionate
Methyltestosterone
Testosterone cypionate
Testosterone
Testosterone enanthate
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone [ Time Frame: Predose up to 72 hours after administration of study drug ] [ Designated as safety issue: No ]
- Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone [ Time Frame: Predose up to 72 hours after administration of study drug ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2012 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Testosterone Unshaved
No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to unshaved axillae in 1 of 6 treatment periods.
|
Drug: Testosterone
Administered topically to axillae
Other Names:
|
|
Experimental: Testosterone Unshaved + Deodorant Spray
Deodorant spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to axillae in 1 of 6 treatment periods.
|
Drug: Testosterone
Administered topically to axillae
Other Names:
Other: Deodorant Spray
Administered topically to axillae
|
|
Experimental: Testosterone Unshaved + Deodorant Stick
Deodorant stick applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to axillae in 1 of 6 treatment periods.
|
Drug: Testosterone
Administered topically to axillae
Other Names:
Other: Deodorant Stick
Administered topically to axillae
|
|
Experimental: Testosterone Unshaved + Deodorant Antiperspirant Stick
Deodorant antiperspirant combination stick applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of Testosterone applied topically in 1 of 6 treatment periods.
|
Drug: Testosterone
Administered topically to axillae
Other Names:
Other: Deodorant and Antiperspirant Combination Stick
Administered topically to axillae
|
|
Experimental: Testosterone Shaved
No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to shaved axillae in 1 of 6 treatment periods.
|
Drug: Testosterone
Administered topically to axillae
Other Names:
|
|
Experimental: Testosterone Shaved + Deodorant Spray
Deodorant spray applied to shaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically in 1 of 6 treatment periods.
|
Drug: Testosterone
Administered topically to axillae
Other Names:
Other: Deodorant Spray
Administered topically to axillae
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Are overtly healthy males, as determined by medical history and physical examination
- Agree to use a reliable method of birth control (e.g. 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 persons 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725451
Locations
| United States, Florida | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Daytona Beach, Florida, United States, 32117 | |
| United States, Indiana | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Evansville, Indiana, United States, 47710 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01725451 History of Changes |
| Other Study ID Numbers: | 15083, I5E-MC-TSBD |
| Study First Received: | November 8, 2012 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Androgens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents |
ClinicalTrials.gov processed this record on May 16, 2013