Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride

Phase 1

Completed

• Conditions: Hypogonadism; Hypogonadism, Male

• Registration Number: NCT00400335
• Lead Sponsor: GlaxoSmithKline

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-14
• Study First Submitted QC: 2006-11-14
• Study First Posted: 2006-11-16
• Status Verified: 2011-02
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
lab tests for relative bioavailability of testosterone and dutasteride,	days 1, 2, 3, 19, 20, 21 & 26-31

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Tacoma, Washington, United States