Clinical Trial: IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An 8-Week, Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Effect of IX-01 on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Lifelong
Brief Summary: The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong premature ejaculation.
Detailed Summary:
Sponsor: Ixchelsis Limited
Current Primary Outcome: Mean fold change in geometric Mean IELT [ Time Frame: Last 4 weeks of treatment compared to baseline ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of participants rating their PE as better or much better, on the Clinical Global Impression of Change (CGIC) scale [ Time Frame: Baseline to the end of treatment (approximately 8 weeks) ]
- Proportion of participants with greater than or equal to (≥) 2.5 fold increase in IELT [ Time Frame: Last 4 weeks of treatment compared to baseline ]
- Mean change in arithmetic IELT [ Time Frame: Last 4 weeks of treatment compared to baseline ]IX-01 versus placebo
- Mean change in score on control of timing of ejaculation [ Time Frame: Last 4 weeks of treatment compared to baseline ]Reported in e-diary
- Mean change in score on ejaculation-related personal distress [ Time Frame: Last 4 weeks of treatment compared to baseline ]Reported in e-diary
- Proportion of participants with ≥ 1 category of improvement in satisfaction with sexual intercourse, on the Premature Ejaculation Profile (PEP) questionnaire [ Time Frame: Baseline to 8 weeks ]
- Proportion of participants with ≥ 1 category of improvement in control over ejaculation during sexual intercourse on the PEP questionnaire [ Time Frame: Baseline to 8 weeks ]
- Proportion of participants with ≥ 1 category of improvement in ejaculation-related distress on the PEP questionnaire [ Time Frame: Baseline to 8 weeks ]
- Proportion of participants with ≥ 1 category of improvement in ejaculation-related interpersonal difficulty on the PEP questionnaire [ Time Frame: Baseline to 8 weeks ]
- Proportion of participants with ≥ 2 category increase in control and ≥ 1 category decrease in personal distress on a Patient Reported Outcome (PRO) measure [ Time Frame: Baseline to 8 weeks ]
- Percentage of intercourse attempts lasting greater than (>) 1 minute [ Time Frame: Last 4 weeks of treatment compared to baseline ]
- Incidence of treatment-emergent adverse events [ Time Frame: Start of Treatment to end of study (approximately 10 weeks) ]
Original Secondary Outcome:
- Proportion of participants rating their PE as better or much better, on the Clinical Global Impression of Change (CGIC) scale [ Time Frame: Baseline to the end of treatment (approximately 8 weeks) ]
- Proportion of participants with greater than or equal to (≥) 2.5 fold increase in IELT [ Time Frame: Last 4 weeks of treatment compared to baseline ]
- Mean change in arithmetic IELT [ Time Frame: Last 4 weeks of treatment compared to baseline ]IX-01 versus placebo
- Mean change in score on control of timing of ejaculation [ Time Frame: Last 4 weeks of treatment compared to baseline ]Reported in e-diary
- Mean change in score on ejaculation-related personal distress [ Time Frame: Last 4 weeks of treatment compared to baseline ]Reported in e-diary
- Proportion of participants with ≥ 1 category of improvement in satisfaction with sexual intercourse, on the Premature Ejaculation Profile (PEP) questionnaire [ Time Frame: Baseline to 8 weeks ]
- Proportion of participants with ≥ 1 category of improvement in control over ejaculation during sexual intercourse on the PEP questionnaire [ Time Frame: Baseline to 8 weeks ]
- Proportion of participants with ≥ 1 category of improvement in ejaculation-related distress on the PEP questionnaire [ Time Frame: Baseline to 8 weeks ]
- Proportion of participants with ≥ 1 category of improvement in ejaculation-related interpersonal difficulty on the PEP questionnaire [ Time Frame: Baseline to 8 weeks ]
- Proportion of participants with ≥ 2 category increase in control and ≥ 1 category increase in personal distress on a Patient Reported Outcome (PRO) measure [ Time Frame: Baseline to 8 weeks ]
- Percentage of intercourse attempts lasting greater than (>) 1 minute [ Time Frame: Last 4 weeks of treatment compared to baseline ]
- Incidence of treatment-emergent adverse events [ Time Frame: Start of Treatment to end of study (approximately 10 weeks) ]
Information By: Ixchelsis Limited
Dates:
Date Received: September 3, 2014
Date Started: September 2014
Date Completion:
Last Updated: September 22, 2016
Last Verified: September 2016