Clinical trial NCT02232425: IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
Official title: An 8-Week, Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Effect of IX-01 on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Lifelong Premature Ejaculation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premature Ejaculation
Lead sponsor: Ixchelsis Limited
Sponsor class: INDUSTRY
Collaborators: name: Carelon Research
name: Novotech (Australia) Pty Limited
name: ICON plc
name: PHT Corporation
First posted: 2014-09-05
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
timeFrame: Last 4 weeks of treatment compared to baseline
Secondary outcomes:
measure: Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale
timeFrame: Baseline to the end of treatment (approximately 8 weeks)
measure: Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)
timeFrame: Last 4 weeks of treatment compared to baseline
measure: Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)
timeFrame: Last 4 weeks of treatment compared to baseline
measure: Mean Change in Score on Control of Timing of Ejaculation
timeFrame: Last 4 weeks of treatment compared to baseline
measure: Mean Change in Score on Ejaculation-related Personal Distress
timeFrame: Last 4 weeks of treatment compared to baseline
measure: Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire
timeFrame: Baseline to 8 weeks
measure: Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire
timeFrame: Baseline to 8 weeks
measure: Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire
timeFrame: Baseline to 8 weeks
measure: Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire
timeFrame: Baseline to 8 weeks
measure: Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure
timeFrame: Baseline to 8 weeks
measure: Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment
timeFrame: Baseline to last 4 weeks on treatment
measure: Incidence of Treatment-emergent Adverse Events
timeFrame: Start of Treatment to end of study (approximately 10 weeks)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
city: Aventura
country: United States
facility: South Florida Medical Research Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Center for Marital and Sexual Health of South Florida
state: Florida
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Camden
country: United States
facility: Cooper Research Institute
state: New Jersey
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital / The Men's Health Center
state: Rhode Island
city: Saint Leonards
country: Australia
facility: Australian Centre for Sexual Health
state: New South Wales
city: Nedlands
country: Australia
facility: Keogh Institute for Medical Research
state: Western Australia
Study officials:
affiliation: Ixchelsis Limited
name: Email Katie.George@Ixchelsis.com
role: STUDY_DIRECTOR
References:
citation: McMahon C, Althof S, Rosen R, Giuliano F, Miner M, Osterloh IH, Muirhead GJ, Harty B; PEPIX Multi-Centre Study Group. The Oxytocin Antagonist Cligosiban Prolongs Intravaginal Ejaculatory Latency and Improves Patient-Reported Outcomes in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Trial (PEPIX). J Sex Med. 2019 Aug;16(8):1178-1187. doi: 10.1016/j.jsxm.2019.05.016.