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.
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- Are participants who have previously completed or withdrawn from this study or any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
