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Efficacy and Tolerability Study of Avanafil in Russia

NCT02503306 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2016-03-17

No results posted yet for this study

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).

Conditions

  • Sexual Function and Fertility Disorders NEC-Erectile Dysfunction

Interventions

DRUG

AVANAFIL

Pharmaceutical form:tablets Route of administration: oral

DRUG

placebo

Pharmaceutical form:tablets Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02503306 on ClinicalTrials.gov