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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01725451
First received: November 8, 2012
Last updated: January 17, 2014
Last verified: January 2014
  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 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.


Condition Intervention Phase
Healthy Participants
Drug: Testosterone
Other: Deodorant Spray
Other: Deodorant and Antiperspirant Combination Spray
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:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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.


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 each unshaved axilla in 1 of 6 treatment periods.
Drug: Testosterone
Administered topically to axillae
Other Names:
  • Axiron
  • LY900011
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 each axilla in 1 of 6 treatment periods.
Drug: Testosterone
Administered topically to axillae
Other Names:
  • Axiron
  • LY900011
Other: Deodorant Spray
Administered topically to axillae
Experimental: Testosterone Unshaved + Deodorant Antiperspirant Spray
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
Administered topically to axillae
Other Names:
  • Axiron
  • LY900011
Other: Deodorant and Antiperspirant Combination Spray
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 to each axilla in 1 of 6 treatment periods.
Drug: Testosterone
Administered topically to axillae
Other Names:
  • Axiron
  • LY900011
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 each shaved axilla in 1 of 6 treatment periods.
Drug: Testosterone
Administered topically to axillae
Other Names:
  • Axiron
  • LY900011
Experimental: Testosterone Shaved + Deodorant Antiperspirant Spray
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
Administered topically to axillae
Other Names:
  • Axiron
  • LY900011
Other: Deodorant and Antiperspirant Combination 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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: January 17, 2014
Last Updated: January 17, 2014
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 September 16, 2014