Trial Outcomes & Findings for A Study of Axiron® in Healthy Participants (NCT NCT02004132)

NCT ID: NCT02004132

Last Updated: 2014-08-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: 12 hours after application of study drug
• Results posted on: 2014-08-19

Participant Flow

Participant milestones

Measure	Axiron 120 mg 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 Study STARTED	12
Overall Study Received Study Drug	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Axiron® in Healthy Participants

Baseline characteristics by cohort

Measure	Axiron 120 mg n=12 Participants 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.
Age, Continuous	38.3 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours after application of study drug

Population: Full analysis set (FAS). Data from all enrolled participants completing the study.

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.

Outcome measures

Measure	Axiron 120 mg n=12 Participants 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.
Amount of Testosterone on T-shirts	7603 micrograms (µg) Standard Deviation 2790

SECONDARY outcome

Timeframe: 12 hours after application of study drug

Population: FAS. Data from all enrolled participants completing the study.

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.

Outcome measures

Measure	Axiron 120 mg n=12 Participants 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.
Amount of Testosterone Following Laundering	260 µg Standard Deviation 407

SECONDARY outcome

Timeframe: 12 hours after application of study drug

Population: FAS. Data from all enrolled participants completing the study.

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.

Outcome measures

Measure	Axiron 120 mg n=12 Participants 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.
Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts Bleached Cotton Terry Cloth	308 µg Standard Deviation 71.9
Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts Wool Jersey Knit Fabric	122 µg Standard Deviation 23.8
Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts 56/44 Cotton/Linen	441 µg Standard Deviation 70.8
Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts Texturized Dacron 56T Double	68.7 µg Standard Deviation 21.0
Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts 87/13 Nylon/Lycra Knit	10402 µg Standard Deviation 1408

Adverse Events

Axiron 120 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Axiron 120 mg n=12 participants at risk 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.
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • Randomization up to 9 days follow-up 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.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Randomization up to 9 days follow-up 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.
Infections and infestations Pharyngitis	8.3% 1/12 • Number of events 1 • Randomization up to 9 days follow-up 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.
Nervous system disorders Headache	16.7% 2/12 • Number of events 2 • Randomization up to 9 days follow-up 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.
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • Number of events 1 • Randomization up to 9 days follow-up 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.
Respiratory, thoracic and mediastinal disorders Dysphonia	8.3% 1/12 • Number of events 1 • Randomization up to 9 days follow-up 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.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	8.3% 1/12 • Number of events 1 • Randomization up to 9 days follow-up 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.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60