IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Intervention: IX-01 400 mg; Placebo; IX-01 800 mg; IX-01 1200 mg
Intervention description: IX-01 400 mg caplet; Placebo caplet(s); IX-01 800 mg (Two 400 mg caplets); IX-01 1200 mg (Three 400 mg caplets)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 239.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Sex; Sexual Dysfunction; IX-01

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:

          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.