IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Intervention: IX-01; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 88.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

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 (<) 4 attempts at sexual intercourse during run-in (screening may be
             extended or patient may be rescreened if there are extenuating circumstances)

          -  A rating of control of ejaculation as fair, good, or very good on the Premature
             Ejaculation Profile (PEP) questionnaire prior to study

          -  Co-existing Erectile Dysfunction - International Index of Erectile Dysfunction (IIEF)
             erectile function domain < 22 during run-in

          -  Concomitant use of Phosphodiesterase 5 (PDE5) inhibitors, intracavernosal injections,
             penile implants, Selective Serotonin Reuptake Inhibitors (SSRI's) or
             Serotonin-Norepinephrine Reuptake Inhibitors (SSNRI's), tricyclic antidepressants (for
             example (e.g.) clomipramine), monoamine oxidase inhibitors, alpha blockers, 5 alpha
             reductase inhibitors (including propecia for hair loss), topical anaesthetics, and/or
             tramadol

          -  History (last 6 months) of use of Botox or similar product to treat premature
             ejaculation

          -  Unwilling to stop other treatments for premature ejaculation (including but not
             limited to pharmacological, herbal, multiple condoms, psychosexual treatment, prior
             masturbation)

          -  Other sexual disorder of patient or partner that could interfere with results

          -  Current active sexually transmitted disease

          -  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

          -  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