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

Ixchelsis Limited239 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

239

Conditions

Premature Ejaculation

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Men aged ≥18 years and ≤60 years in stable (≥6 months) heterosexual relationship and who have lifelong PE. 2. Premature ejaculation ≤1 minute on ≥75% attempts at sexual intercourse during the run-in period. 3. Meets other aspects of ISSM definition. 4. 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. 5. Partner not planning pregnancy and willing to use contraception (unless not of childbearing potential, e.g, surgically sterilized). 6. Willing to limit use of alcohol on days in which he takes study drug. 7. Capable of giving written informed consent. Exclusion Criteria: 1. IELT value \>2 minutes during the run-in period. 2. \<4 attempts at sexual intercourse during the run-in period. 3. Any patient who rates his control of ejaculation as fair, good, or very good. 4. Any patient who rates his ejaculation-related "personal distress" as "not at all" or "a little bit". 5. Erectile Dysfunction. 6. 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. 7. History (last 6 months) of use of Botox or similar product to treat PE. 8. Has received IX-01 in a previous clinical study. 9. Unwilling to stop other treatments for PE (including but not limited to pharmacological, sex therapy, psychotherapy multiple condoms, and prior masturbation). 10. Any other sexual disorder of patient or partner that could interfere with results. 11. Any current sexually transmitted disease. 12. Any major medical condition of patient that could interfere with ability to have sexual activity and/or require hospital treatment. 13. Body mass index (BMI) \>40 kg/m2 or weight \<60 kg. 14. Participation in a clinical drug study anytime during the 30 days prior to screening. 15. Human immunodeficiency virus (HIV), hepatitis B. 16. History of prostate disease or clinically significant prostate disease. 17. History of myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, clinically evident congestive heart failure, cardiac pacemaker, or cerebrovascular accident. 18. Known or suspected history of significant cardiac arrhythmias. 19. History of drug-induced allergic reactions including skin reactions. 20. Significant psychiatric disease and/or risk of suicidal tendency. 21. History of or other evidence of recent alcohol or drug abuse.

Outcomes

Primary Outcomes

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.

Time frame: Last 4 weeks of treatment compared to baseline

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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'.

Time frame: 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'.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: Last 4 weeks of treatment compared to baseline

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

Overview

Conditions

Interventions

Eligibility

Locations (29)

Outcomes

Primary Outcomes

Secondary Outcomes