A Study of Axiron® in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Single-Dose Study to Evaluate Testosterone on Clothing After Axiron® Use in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004132
• Other study ID #: 15281
• Secondary ID: I5E-EW-TSBE
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2013
• Last updated: July 29, 2014
• Start date: December 2013
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study involves application of Axiron to each underarm. The study will evaluate the transfer of testosterone from underarms to the clothing items that the participant is wearing and other fabric items washed with participant's' clothes. The study is approximately 6 days, not including screening. Screening is required within 28 days prior to the start of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Are overtly healthy males, as determined by medical history and physical examination, or males who have been on stable medication for at least 1 month and have no significant clinical conditions.

• Agree to use a reliable method of birth control (for example: condom or vasectomy) during the study and for 3 months following the Axiron dose

• Have clinical laboratory test results within the normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

• 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 Lilly and the ethical review board (ERB) governing the site

Exclusion Criteria:

• Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

• Are participants who have previously completed or withdrawn from this study or any other study investigating Axiron in the past 3 months

• 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

• Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders constituting a risk when taking the study medication or 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

• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening

• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies

• Show evidence of hepatitis C and/or positive hepatitis C antibody

• Show evidence of hepatitis B and/or positive hepatitis B surface antigen

• Use of any topical testosterone replacement therapy within the 3 months prior to study entry through study discharge, except for use of Axiron as directed by study procedures

• Use of parenteral testosterone replacement (testosterone enthanate, testosterone cypionate) within the 30 days prior to screening. Use of long acting intramuscular testosterone undecanoate 6 months prior to screening, or use of testosterone pellets 12 months prior to screening

• Have a dermatologic condition in the underarm area that might be exacerbated by topical testosterone replacement therapy, in the opinion of the investigator

• In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Axiron
Solution administered topically using pump and applicator

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Testosterone on T-shirts	This is a summary of the amounts of testosterone measured on a 10 centimeters (cm) × 10 cm of material excised from the underarm area of participant's unwashed t-shirt halves.	12 hours after application of study drug	No
Secondary	Amount of Testosterone Following Laundering	This is a summary of the amounts of testosterone measured on a 10 cm × 10 cm of material excised from the underarm area of washed t-shirt halves following laundering in a standard washing machine.	12 hours after application of study drug	No
Secondary	Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts	This is a summary of the amounts of testosterone measured on unworn textile items washed with t-shirt halves exposed to testosterone in a standard washing machine. Total amounts of testosterone on each laundered item other than the t-shirt halves was calculated based on the weight of the fabric sample analyzed and the total weight of the item, assuming a uniform distribution of testosterone across each item as: (weight of laundered item / weight of laundered sample) x amount of testosterone on laundered sample.	12 hours after application of study drug	No