A Study of Axiron® in Healthy Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Axiron

Study type

Interventional

Funder types

Industry

Identifiers

NCT02004132

15281

I5E-EW-TSBE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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Are participants who have previously completed or withdrawn from this study or any other study investigating Axiron in the past 3 months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