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

AbbVie24 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Testosterone Gel 1.62%DRUG

5 grams

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Maximum Plasma Concentration observed (Cmax)

Maximum plasma concentration observed (Cmax) of total testosterone

Time frame: Up to 5 days

Area Under the Plasma Concentration-time Curve (AUC)

Area under the plasma concentration-time curve (AUC) of total testosterone

Time frame: Up to 5 days

Average Plasma Concentration observed (Cav)

Average Plasma Concentration observed (Cav) of total testosterone

Time frame: Up to 5 days

Data from ClinicalTrials.gov

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