Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02503306 | Efficacy and Tolerability Study of Avanafil in Russia | PHASE3 | COMPLETED | 189 | — | — | Jul 1, 2015 | Mar 1, 2016 | Mar 17, 2016 | 1 | Russia |
| Arm | Type | Description |
|---|---|---|
| Avanafil dose 1 | EXPERIMENTAL | 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 | EXPERIMENTAL | 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_COMPARATOR | 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 |
| Name | Type | Description |
|---|---|---|
| AVANAFIL | DRUG | Pharmaceutical form:tablets Route of administration: oral |
| placebo | DRUG | Pharmaceutical form:tablets Route of administration: oral |
Inclusion criteria: * Male subjects, age ≥18 years. * Minimum 6-month history of mild to severe erectile dysfunction prior to the enrollment into the study. * Subject is in a monogamous, heterosexual relationship for at least 3 months prior to the enrollment into the study. * Subject agrees to make...