Phase 2
N=88
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
Premature Ejaculation
Bottom Line
View on ClinicalTrials.gov: NCT02232425 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) — 2.1; 1.1 No units for fold change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IX-01 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Ixchelsis Limited
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT) |
2.1; 1.1 | — |
| SECONDARY Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale |
0.17; 0; 0.44; 0.13 | — |
| SECONDARY Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT) |
0.31; 0.07 | — |
| SECONDARY Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time) |
3.6; 1.8 | — |
| SECONDARY Mean Change in Score on Control of Timing of Ejaculation |
0.42; -0.03 | — |
| SECONDARY Mean Change in Score on Ejaculation-related Personal Distress |
0.63; 0.03 | — |
| SECONDARY Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire |
0.53; 0.30 | — |
| SECONDARY Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire |
0.56; 0.36 | — |
| SECONDARY Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire |
0.60; 0.36 | — |
| SECONDARY Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire |
0.60; 0.48 | — |
| SECONDARY Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure |
0.17; 0 | — |
| SECONDARY Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment |
37.6; 13.5 | — |
| SECONDARY Incidence of Treatment-emergent Adverse Events |
12; 9 | — |
Summary
The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong premature ejaculation.
Eligibility Criteria
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 aspects of the International Society for Sexual Medicine (ISSM) definition for lifelong premature ejaculation (PE), including inability to delay ejaculation on all or nearly all vaginal penetrations and negative personal consequences such as distress, bother and frustration
- Willing to attempt intercourse at least 4 times during run-in period and at least 8 more times during double-blind part of the study
- Not planning pregnancy with his partner and he is willing to use contraception (unless not of child-bearing potential, e.g., surgically sterilised)
- Willing to limit use of alcohol on days in which they take study drug (not more than three drinks, where one drink is defined as a 12 ounce (oz), 360 milliliter (mL) bottle of beer, a 5 oz (150 mL) glass of wine, or a 1½ oz (45 mL distilled spirits)
- Capable of giving written informed consent
Exclusion Criteria
- An Intravaginal Ejaculatory Latency Time (IELT) value ≥ 2 minutes during run-in period
- Less than ( 40 kg/m2
- Participation in a clinical drug trial anytime during the 30 days prior to screening
- Human Immunodeficiency Virus (HIV) or hepatitis B
- History of 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
- Cardiac arrhythmia: significant cardiac arrhythmia shown on Electrocardiogram (ECG), or a known or suspected history of significant cardiac arrhythmias within last six months
- History of congenital QT prolongation and/ corrected QT (QTc) interval > 450 milliseconds (msec) using the Bazett formula
- Mean systolic cuff blood pressure (BP) > 140 millimeter of mercury (mmHg), as assessed by up to three measurements taken in sequence within 5-10 minutes of last measure
- Mean diastolic cuff BP > 90 mmHg, as assessed by up to three measurements taken in sequence within 5-10 minutes of the last measure
- Major psychiatric disease or risk of suicidal tendency as assessed by clinical evaluation and Patient Health Questionnaire (PHQ)-9 and Columbia Suicide Assessment
- PHQ-9 questionnaire total score > 9 and/or score > 0 for question 9 of PHQ-9, and/or suicidal ideation or behavior as assessed by Columbia Suicide Assessment
- Clinically significant abnormal laboratory function test results (including liver enzymes > 2 x Upper Limit of Normal (ULN) or bilirubin > 1.5 x ULN)
- Taking Cytochrome P450 3A4 (CYP3A4) inducers, or moderate and potent CYP3A4 inhibitors
Data sourced from ClinicalTrials.gov (NCT02232425). 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.