Clinical Trial: IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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
Brief 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.
Detailed Summary:
Sponsor: Ixchelsis Limited
Current Primary Outcome: Change in Geometric Mean (GM) IELT over the treatment assessment period compared with baseline [ Time Frame: Approximately 8 weeks of treatment ]
Original Primary Outcome: Change in GM IELT over the treatment assessment period compared with baseline [ Time Frame: Approximately 8 weeks of treatment ]
Current Secondary Outcome:
- Fold change in GM IELT over the treatment assessment period compared with baseline [ Time Frame: Approximately 8 weeks of treatment ]IX-01 versus placebo
- Proportion of patients with ≥2.5-fold increase in GM IELT over the treatment assessment period compared with baseline [ Time Frame: Approximately 8 weeks of treatment ]IX-01 versus placebo
- Proportion of patients rating their PE as improved per the Clinical Global Impression of Change (CGIC) questionnaire [ Time Frame: Approximately 8 weeks of treatment ]
- Proportion of patients achieving mean change in category of ≥1 or ≥2 on control of timing of ejaculation [ Time Frame: Approximately 8 weeks of treatment ]
- Proportion of patients achieving mean change in category of ≥1 or ≥2 in ejaculation related personal distress [ Time Frame: Approximately 8 weeks of treatment ]
- Proportions of patients achieving change in category of ≥2 on control of timing of ejaculation and achieving change in category of ≥1 in ejaculation-related personal distress at end of treatment [ Time Frame: Approximately 8 weeks of treatment ]
- Mean change from baseline in score on control of ejaculation over the treatment assessment period [ Time Frame: Approximately 8 weeks of treatment ]
- Mean change from baseline in score on ejaculation-related personal distress over the treatment assessment period [ Time Frame: Approximately 8 weeks of treatment ]
Original Secondary Outcome:
- Fold change in GM IELT over the treatment assessment period compared with baseline [ Time Frame: Approximately 8 weeks of treatment ]IX-01 versus placebo
- Proportion of patients with ≥2.5-fold increase in GM IELT over the treatment assessment period compared with baseline [ Time Frame: Approximately 8 weeks of treatment ]IX-01 versus placebo
- Proportion of patients rating their PE as improved per the CGIC questionnaire [ Time Frame: Approximately 8 weeks of treatment ]
- Proportion of patients achieving mean change in category of ≥1 or ≥2 on control of timing of ejaculation (PEP) [ Time Frame: Approximately 8 weeks of treatment ]
- Proportion of patients achieving mean change in category of ≥1 or ≥2 in ejaculation related personal distress (PEP) [ Time Frame: Approximately 8 weeks of treatment ]
- Proportions of patients achieving change in category of ≥2 on control of timing of ejaculation (PEP) and achieving change in category of ≥1 in ejaculation-related personal distress (PEP) at end of treatment [ Time Frame: Approximately 8 weeks of treatment ]
- Mean change from baseline in score on control of ejaculation (e-diary) over the treatment assessment period [ Time Frame: Approximately 8 weeks of treatment ]
- Mean change from baseline in score on ejaculation-related personal distress (e-diary) over the treatment assessment period [ Time Frame: Approximately 8 weeks of treatment ]
Information By: Ixchelsis Limited
Dates:
Date Received: February 14, 2017
Date Started: February 28, 2017
Date Completion: December 1, 2017
Last Updated: May 2, 2017
Last Verified: May 2017