An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components

GlaxoSmithKline1 site in 1 country60 target enrollmentOctober 2006

ConditionsHypogonadism Hypogonadism, Male

DrugsNanomilled testosterone commercially available dutasteride Nanomilled dutasteride

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hypogonadism
Sponsor: GlaxoSmithKline
Enrollment: 60
Locations: 1
Primary Endpoint: lab tests for relative bioavailability of testosterone and dutasteride,
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

lab tests for relative bioavailability of testosterone and dutasteride,

Time Frame: days 1, 2, 3, 19, 20, 21 & 26-31

Secondary Outcomes

lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,(days 1, 2, 3, 19, 20, 21 & 26-31.)
safety lab tests of various testosterone/dutasteride formulations,(days 1, 2, 3, 19, 20, 21 & 26-31.)