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A Study of Axiron® in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02004132
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : August 19, 2014
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Axiron Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Single-Dose Study to Evaluate Testosterone on Clothing After Axiron® Use in Healthy Male Subjects
Study Start Date : December 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013


Arm Intervention/treatment
Experimental: Axiron
Axiron administered topically via metered dose pump to each underarm on Day 1
Drug: Axiron
Solution administered topically using pump and applicator
Other Names:
  • LY900011
  • Testosterone




Primary Outcome Measures :
  1. Amount of Testosterone on T-shirts [ Time Frame: 12 hours after application of study drug ]
    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.


Secondary Outcome Measures :
  1. Amount of Testosterone Following Laundering [ Time Frame: 12 hours after application of study drug ]
    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.

  2. Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts [ Time Frame: 12 hours after application of study drug ]

    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.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004132


Locations
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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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02004132     History of Changes
Other Study ID Numbers: 15281
I5E-EW-TSBE ( Other Identifier: Eli Lilly and Company )
First Posted: December 6, 2013    Key Record Dates
Results First Posted: August 19, 2014
Last Update Posted: August 19, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents