NCT01100021

Hemodynamic Study of Avanafil and Two α-Adrenergic Blockers,Doxazosin and Tamsulosin

A Phase 1, Single-centre, Double-blind, Randomized, Placebo-controlled, Two-cohort, Two-period Crossover Study of the Hemodynamic Interactions Between Avanafil and Two α-Adrenergic Blockers, Doxazosin and Tamsulosin, in Middle-aged Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: Male
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to see if avanafil causes any changes in blood pressure and pulse rate when taken with doxazosin or tamsulosin.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Tamsulosin and avanafil	tamsulosin - 0.4mg daily for 18 days; avanafil - 200 mg 1 x 2 days
DRUG	Doxazosin and avanafil	doxazosin - 1 mg 1 x 1 day; 2 mg 1 x 2 days; 4 mg 1 x 4 days; 8 mg 1 x 11 days; avanafil - 200 mg 1 x 1 day

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2010-04-08
• Last updated: 2011-01-07

Locations

1 site across 1 country: United States