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

NCT01725451 | Completed Phase 1 Results

• 2 other identifiers: 15083I5E-MC-TSBD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (6)

Testosterone Unshaved

EXPERIMENTAL

No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods.

Drug: Testosterone

Testosterone Unshaved + Deodorant Spray

EXPERIMENTAL

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; Other: Deodorant Spray

Testosterone Unshaved + Deodorant Antiperspirant Spray

EXPERIMENTAL

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; Other: Deodorant and Antiperspirant Combination Spray

Testosterone Unshaved + Deodorant Antiperspirant Stick

EXPERIMENTAL

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; Other: Deodorant and Antiperspirant Combination Stick

Testosterone Shaved

EXPERIMENTAL

No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods.

Drug: Testosterone

Testosterone Shaved + Deodorant Antiperspirant Spray

EXPERIMENTAL

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; Other: Deodorant and Antiperspirant Combination Spray

Interventions

Testosterone DRUG

Administered topically to axillae

Also known as: Axiron, LY900011

Testosterone Shaved; Testosterone Shaved + Deodorant Antiperspirant Spray; Testosterone Unshaved; Testosterone Unshaved + Deodorant Antiperspirant Spray; Testosterone Unshaved + Deodorant Antiperspirant Stick; Testosterone Unshaved + Deodorant Spray

Deodorant Spray OTHER

Administered topically to axillae

Testosterone Unshaved + Deodorant Spray

Deodorant and Antiperspirant Combination Spray OTHER

Administered topically to axillae

Testosterone Shaved + Deodorant Antiperspirant Spray; Testosterone Unshaved + Deodorant Antiperspirant Spray

Deodorant and Antiperspirant Combination Stick OTHER

Administered topically to axillae

Testosterone Unshaved + Deodorant Antiperspirant Stick

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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, 32117, United States

Location

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, 47710, United States

Location

Related Publications (1)

• Small DS, Ni X, Polzer P, Vart R, Satonin DK, Mitchell MI. Effect of deodorant and antiperspirant use and presence or absence of axillary hair on absorption of testosterone 2% solution applied to men's axillae. J Sex Med. 2014 Nov;11(11):2809-17. doi: 10.1111/jsm.12658. Epub 2014 Aug 14.

  PMID: 25123988 DERIVED

MeSH Terms

Interventions

Testosterone; Testosterone Propionate; Deodorants

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 12, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 16, 2014
• Results First Posted: March 3, 2014

Record last verified: 2014-10

Locations

US (2)