Efficacy and Tolerability Study of Avanafil in Russia

Phase 3

Completed

• Conditions: Sexual Function and Fertility Disorders NEC-Erectile Dysfunction
• Interventions: Drug: AVANAFIL; Drug: placebo

• Registration Number: NCT02503306
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 189

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avanafil dose 1	AVANAFIL	Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period
Avanafil dose 2	AVANAFIL	Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period
Placebo	placebo	Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period

Primary Outcome Measures

Name	Time	Method
Change in the percentage of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse	12 weeks
Change in the percentage of sexual attempts in which subjects are able to insert the penis into the partner's vagina	8 weeks
Change from baseline in EF score	baseline and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with adverse events	12 weeks
Change from baseline in IIEF-EF risk scores	baseline and 8 weeks