Sexual Function and Fertility Disorders NEC-Erectile Dysfunction Clinical Trial
Official title:
Clinical Trial on Efficacy and Tolerability of Two Different Single Doses of Avanafil in Russia
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).
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment