An Open-Label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% Applied to the Upper Arms and Shoulders and Use of a T-shirt Barrier

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Testosterone Gel 1.62%

• Registration Number: NCT01130298
• Lead Sponsor: AbbVie

Brief Summary

Single-center, single dose, open-label study in healthy male and female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.

Detailed Description

Single-center, single dose, open-label study in 12 healthy male and 12 healthy female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Status Verified: 2011-06
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2017-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Testosterone Gel 1.62%	-

Primary Outcome Measures

Name	Time	Method
Average Plasma Concentration observed (Cav)	Up to 5 days	Average Plasma Concentration observed (Cav) of total testosterone
Maximum Plasma Concentration observed (Cmax)	Up to 5 days	Maximum plasma concentration observed (Cmax) of total testosterone
Area Under the Plasma Concentration-time Curve (AUC)	Up to 5 days	Area under the plasma concentration-time curve (AUC) of total testosterone