Phase 2
N=239
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
Premature Ejaculation
Bottom Line
View on ClinicalTrials.gov: NCT03055806 ↗Enrolled (actual)
239
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period — 42.6; 39.7; 44.5; 29.2 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IX-01 400 mg (Drug); Placebo (Drug); IX-01 800 mg (Drug); IX-01 1200 mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Ixchelsis Limited
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period |
42.6; 39.7; 44.5; 29.2 | — |
| SECONDARY Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline |
1.77; 1.56; 1.79; 1.54 | — |
| SECONDARY Proportion of Patients With ≥2.5-fold Increase in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period Compared With Baseline |
0.30; 0.20; 0.26; 0.20 | — |
| SECONDARY Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire |
0.12; 0.05; 0.07; 0.07; 0; 0.02 | — |
| SECONDARY Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 on Control of Timing of Ejaculation on the Premature Ejaculation Profile (PEP) Questionnaire. |
0.35; 0.18; 0.33; 0.18 | — |
| SECONDARY Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire |
0.37; 0.25; 0.39; 0.23 | — |
| SECONDARY Proportion 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 |
0.13; 0.11; 0.25; 0.08 | — |
| SECONDARY Mean Change From Baseline in Score on Control of Ejaculation |
0.55; 0.46; 0.58; 0.32 | — |
| SECONDARY Mean Change From Baseline in Score on Ejaculation-related Personal Distress |
0.73; 0.38; 0.58; 0.51 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men aged ≥18 years and ≤60 years in stable (≥6 months) heterosexual relationship and who have lifelong PE.
- Premature ejaculation ≤1 minute on ≥75% attempts at sexual intercourse during the run-in period.
- Meets other aspects of ISSM definition.
- Patient and partner willing to attempt intercourse at least 4 times during the run-in period and at least 8 additional times during the double-blind part of the study.
- Partner not planning pregnancy and willing to use contraception (unless not of childbearing potential, e.g, surgically sterilized).
- Willing to limit use of alcohol on days in which he takes study drug.
- Capable of giving written informed consent.
Exclusion Criteria
- IELT value >2 minutes during the run-in period.
- 40 kg/m2 or weight <60 kg.
- Participation in a clinical drug study anytime during the 30 days prior to screening.
- Human immunodeficiency virus (HIV), hepatitis B.
- History of prostate disease or clinically significant prostate disease.
- History of myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, clinically evident congestive heart failure, cardiac pacemaker, or cerebrovascular accident.
- Known or suspected history of significant cardiac arrhythmias.
- History of drug-induced allergic reactions including skin reactions.
- Significant psychiatric disease and/or risk of suicidal tendency.
- History of or other evidence of recent alcohol or drug abuse.
Data sourced from ClinicalTrials.gov (NCT03055806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.