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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Testosterone Gel 1.62%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01130298

S176.1.011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Testosterone Gel 1.62%