A Study of Axiron® in Healthy Participants
Study Details
Study Description
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 |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| 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:
|
Outcome Measures
Primary Outcome Measures
- Amount of Testosterone on T-shirts [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
- Amount of Testosterone Following Laundering [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.
- Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15281
- I5E-EW-TSBE
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Axiron 120 mg |
|---|---|
| Arm/Group Description | Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump. |
| Period Title: Overall Study | |
| STARTED | 12 |
| Received Study Drug | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Axiron 120 mg |
|---|---|
| Arm/Group Description | Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump. |
| Overall Participants | 12 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
38.3
(10.6)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
12
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
3
25%
|
| Not Hispanic or Latino |
9
75%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
5
41.7%
|
| White |
6
50%
|
| More than one race |
1
8.3%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
12
100%
|
Outcome Measures
| Title | Amount of Testosterone on T-shirts |
|---|---|
| Description | 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. |
| Time Frame | 12 hours after application of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS). Data from all enrolled participants completing the study. |
| Arm/Group Title | Axiron 120 mg |
|---|---|
| Arm/Group Description | Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump. |
| Measure Participants | 12 |
| Mean (Standard Deviation) [micrograms (µg)] |
7603
(2790)
|
| Title | Amount of Testosterone Following Laundering |
|---|---|
| Description | 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. |
| Time Frame | 12 hours after application of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS. Data from all enrolled participants completing the study. |
| Arm/Group Title | Axiron 120 mg |
|---|---|
| Arm/Group Description | Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump. |
| Measure Participants | 12 |
| Mean (Standard Deviation) [µg] |
260
(407)
|
| Title | Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts |
|---|---|
| Description | 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. |
| Time Frame | 12 hours after application of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS. Data from all enrolled participants completing the study. |
| Arm/Group Title | Axiron 120 mg |
|---|---|
| Arm/Group Description | Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump. |
| Measure Participants | 12 |
| Bleached Cotton Terry Cloth |
308
(71.9)
|
| Wool Jersey Knit Fabric |
122
(23.8)
|
| 56/44 Cotton/Linen |
441
(70.8)
|
| Texturized Dacron 56T Double |
68.7
(21.0)
|
| 87/13 Nylon/Lycra Knit |
10402
(1408)
|
Adverse Events
| Time Frame | Randomization up to 9 days follow-up | |
|---|---|---|
| Adverse Event Reporting Description | Events deemed to be serious adverse events (SAEs) by the Investigator as related to study drug administration were collected during the study and up to 9 days following study drug administration. | |
| Arm/Group Title | Axiron 120 mg | |
| Arm/Group Description | Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump. | |
All Cause Mortality |
||
| Axiron 120 mg | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Axiron 120 mg | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Axiron 120 mg | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/12 (16.7%) | |
| Gastrointestinal disorders | ||
| Nausea | 1/12 (8.3%) | 1 |
| Vomiting | 1/12 (8.3%) | 1 |
| Infections and infestations | ||
| Pharyngitis | 1/12 (8.3%) | 1 |
| Nervous system disorders | ||
| Headache | 2/12 (16.7%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 1/12 (8.3%) | 1 |
| Dysphonia | 1/12 (8.3%) | 1 |
| Rhinorrhoea | 1/12 (8.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
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