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
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Axiron||Phase 1|
|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|
Axiron administered topically via metered dose pump to each underarm on Day 1
Solution administered topically using pump and applicator
- 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.
- 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.
- 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.
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
|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|
|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|