NCT03055806

IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)

A Phase 2b, 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of 3 Different Dose Levels of IX-01 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (PE)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Ixchelsis Limited · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2b, 8-week, double-blind, placebo-controlled, parallel group study to evaluate the effect of 3 different dose levels of IX-01 on IELT and patient-reported outcome in men with lifelong PE. Men with self-reported lifelong PE (International Society for Sexual Medicine (ISSM) definition) and in stable heterosexual relationship will undergo a 4-week run-in period during which they will be asked to attempt intercourse at least 4 times. Men with IELT ≤ 1 minute on at least 75% of attempts at intercourse during the no-treatment run-in period will be randomized for the double-blind phase of the study. In the double-blind phase of the study, men will be asked to take study drug 1 to 6 hours prior to sexual activity. Men and partners will be asked to attempt intercourse a minimum of 8 times during the 8 week double-blind study treatment. The patient or partner will record the IELT on each occasion by use of a stopwatch.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	IX-01 400 mg	IX-01 400 mg caplet
DRUG	Placebo	Placebo caplet(s)
DRUG	IX-01 800 mg	IX-01 800 mg (Two 400 mg caplets)
DRUG	IX-01 1200 mg	IX-01 1200 mg (Three 400 mg caplets)

Timeline

• Start date: 2017-02-28
• Primary completion: 2017-11-17
• Completion: 2017-12-06
• First posted: 2017-02-16
• Last updated: 2019-10-07
• Results posted: 2019-10-07

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated drug study