NCT00398580

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

A Phase II, 28-Day, Randomized, Parallel-Group, Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone (150-400mg) Co-administered With 0.25mg Dutasteride Compared With 400mg Testosterone Alone and 0.25mg Dutasteride Alone in the Treatment of Hypogonadism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypogonadism
• Hypogonadism, Male

Interventions

Type	Name	Description
DRUG	Nanomilled testosterone
DRUG	Nanomilled dutasteride
DRUG	commercially available dutasteride

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-11-10
• Last updated: 2017-05-30

Locations

7 sites across 1 country: United States