Clinical Trials/NCT01130298

NCT01130298

Completed

Phase 1

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

AbbVie0 sites24 target enrollmentMay 2010

ConditionsHealthy

InterventionsTestosterone Gel 1.62%

DrugsTestosterone Gel 1.62%

Overview

Phase: Phase 1
Intervention: Testosterone Gel 1.62%
Conditions: Healthy
Sponsor: AbbVie
Enrollment: 24
Primary Endpoint: Average Plasma Concentration observed (Cav)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

May 2010

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1

Intervention: Testosterone Gel 1.62%

Outcomes

Primary Outcomes

Average Plasma Concentration observed (Cav)

Time Frame: Up to 5 days

Average Plasma Concentration observed (Cav) of total testosterone

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

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