NCT02503306

Efficacy and Tolerability Study of Avanafil in Russia

Clinical Trial on Efficacy and Tolerability of Two Different Single Doses of Avanafil in Russia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: o To assess the change in percent of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse between the run-in period and treatment period: * The change in percent of sexual attempts in which subjects are able to insert the penis into the partner's vagina. * The change in score on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire. Secondary Objective: o To evaluate the safety and tolerability of avanafil in patients with erectile dysfunction (ED).

Detailed description

The total study duration per patient will be up to 12 weeks, consisting of an 8-week treatment period and a 4-week run-in period.

Conditions

• Sexual Function and Fertility Disorders NEC-Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	AVANAFIL	Pharmaceutical form:tablets Route of administration: oral
DRUG	placebo	Pharmaceutical form:tablets Route of administration: oral

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-07-20
• Last updated: 2016-03-17

Locations

1 site across 1 country: Russia