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

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

BMI between 20-35 kg/m^2 inclusive.

Exclusion criteria

Males: history, current or suspected prostate or breast cancer.
Females: pregnant or lactating.

Treatment and study plan

Testosterone gel 1.62%

Drug

5 grams

Primary outcomes

Maximum Plasma Concentration observed (Cmax)

Time frame: Up to 5 days

Maximum plasma concentration observed (Cmax) of total testosterone
Area Under the Plasma Concentration-time Curve (AUC)

Time frame: Up to 5 days

Area under the plasma concentration-time curve (AUC) of total testosterone
Average Plasma Concentration observed (Cav)

Time frame: Up to 5 days

Average Plasma Concentration observed (Cav) of total testosterone

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: May 26, 2010
Registry last updated: Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed