Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males

AbbVie

Status and phase: Completed; Phase 1

Conditions: Hypogonadism

Treatments: Drug: Testosterone Gel 1.62%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01133548

S176.1.010

Details and patient eligibility

About

To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

Full description

To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.

Enrollment: 62 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Hypogonadal males
2. Screening testosterone <300 ng/dL

Exclusion Criteria

1. Smokers
2. Previous history of or current or suspected prostate or breast cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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62 participants in 1 patient group

1

Experimental group

Description:

Testosterone Gel 1.62%

Treatment:

Drug: Testosterone Gel 1.62%

Drug: Testosterone Gel 1.62%