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

NCT01130298 Phase 1 COMPLETED

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.

Details

Lead sponsor	AbbVie
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2010-05
Completion	2010-05

Conditions

• Healthy

Interventions

• Testosterone Gel 1.62%

Primary outcomes

• 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
• Average Plasma Concentration observed (Cav) — Up to 5 days
  Average Plasma Concentration observed (Cav) of total testosterone