28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men

Phase 2

Completed

• Conditions: Hypogonadism; Hypogonadism, Male

• Registration Number: NCT00398580
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-08
• Study First Submitted QC: 2006-11-08
• Study First Posted: 2006-11-10
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

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
Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine	days 1 and 28

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride	days 1 and 28.
Testosterone concentration .	on days 1 and 28
Anabolic & androgenic Pharmacodynamic biomarkers	pre- and post-dose

Trial Locations

Locations (1)

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