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 24 enrolled AbbVie

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2010-05
Primary completion: 2010-05
Completion: 2010-05

Publications

Results Stahlman J, Britto M, Fitzpatrick S, McWhirter C, Testino SA, Brennan JJ, Zumbrunnen TL. Serum testosterone levels in non-dosed females after secondary exposure to 1.62% testosterone gel: effects of clothing barrier on testosterone absorption. Curr Med Res Opin. 2012 Feb;28(2):291-301. doi: 10.1185/03007995.2011.652732. Epub 2012 Jan 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Testosterone	Small molecule	5 g	Topical

Indications

No indication recorded.