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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02232425 | IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE) | PHASE2 | COMPLETED | 88 | — | — | Sep 1, 2014 | Oct 1, 2015 | Aug 17, 2020 | 10 | United States, Australia |
IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred
| Arm | Type | Description |
|---|---|---|
| Drug: IX-01 | EXPERIMENTAL | Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity |
| Placebo | PLACEBO_COMPARATOR | Two to four capsules administered orally, 1-6 hours prior to sexual activity |
| Name | Type | Description |
|---|---|---|
| IX-01 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * In stable (≥ 6 months) heterosexual relationship * Have life-long (primary) premature ejaculation * Have premature ejaculation confirmed by Intravaginal Ejaculatory Latency Time (IELT) less than or equal to (≤) 1 minute on ≥ 75% attempts at sexual intercourse * Meet other aspe...