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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Drug: IX-01 400 mg
* Drug: Placebo
* Drug: IX-01 800 mg
* Drug: IX-01 1200 mg


Participation Criteria
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Eligibility Criteria
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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. <4 attempts at sexual intercourse during the run-in period. Any patient who rates his control of ejaculation as fair, good, or very good. Any patient who rates his ejaculation-related personal distress as not at all or a little bit. Erectile Dysfunction. Concomitant use of phosphodiesterase type 5 (PDE5) inhibitors, selective serotonin reuptake inhibitor (SSRIs)/selective serotonin norepinephrine reuptake inhibitor (SSNRIs), monoamine oxidase inhibitors, alpha blockers, 5-alpha reductase inhibitors, topical anesthetics, and/or tramadol. History (last 6 months) of use of Botox or similar product to treat PE. Has received IX-01 in a previous clinical study. Unwilling to stop other treatments for PE (including but not limited to pharmacological, sex therapy, psychotherapy multiple condoms, and prior masturbation). Any other sexual disorder of patient or partner that could interfere with results. Any current sexually transmitted disease. Any major medical condition of patient that could interfere with ability to have sexual activity and/or require hospital treatment. Body mass index (BMI) >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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IX-01 1200 mg<br>1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity | Drug: IX-01 1200 mg<br>* IX-01 1200 mg (Three 400 mg caplets)<br>|
| Placebo Comparator: Placebo<br>Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity | Drug: Placebo<br>* Placebo caplet(s)<br>|
| Experimental: IX-01 800 mg<br>800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity | Drug: Placebo<br>* Placebo caplet(s)<br>Drug: IX-01 800 mg<br>* IX-01 800 mg (Two 400 mg caplets)<br>|
| Experimental: IX-01 400 mg<br>400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity | Drug: IX-01 400 mg<br>* IX-01 400 mg caplet<br>Drug: Placebo<br>* Placebo caplet(s)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period | Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded by the patient or partner using the stopwatch provided. | Last 4 weeks of treatment compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline | Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded using the stopwatch provided. | Last 4 weeks of treatment compared to baseline | 
| 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 | Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was measured using the stopwatch provided. | Last 4 weeks of treatment compared to baseline | 
| Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire | 7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses [better (2) or much better (3)] on this scale. | Baseline to the end of treatment (approximately 8 weeks) | 
| 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. | Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer). A mean change in category of ≥1 or ≥2 corresponds to improving control from 'very poor' to 'fair', 'good', or 'very good'; or from 'poor' to 'fair', 'good', or 'very good'. | Baseline to the end of treatment (approximately 8 weeks) | 
| Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire | Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement. A change in category of ≥1 or ≥2 corresponds to improving distress from 'extremely' to 'moderately', 'a little bit' or 'not at all'; or from 'quite a bit' to 'moderately', 'a little bit' or 'not at all'; or from 'moderately' to 'a little bit' or 'not at all'. | Baseline to the end of treatment (approximately 8 weeks) | 
| 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 | Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer). | Baseline to the end of treatment (approximately 8 weeks) | 
| Mean Change From Baseline in Score on Control of Ejaculation | Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer scored as 0) to very good (this is the best answer scored as 4). | Last 4 weeks of treatment compared to baseline | 
| Mean Change From Baseline in Score on Ejaculation-related Personal Distress | Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement. | Last 4 weeks of treatment compared to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sex, Sexual Dysfunction, IX-01