NCT02232425已完成2 期
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
Ixchelsis Limited10 个研究点 分布在 2 个国家目标入组 88 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 10
- 主要终点
- Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
研究概览
简要总结
The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong premature ejaculation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
Two to four capsules administered orally, 1-6 hours prior to sexual activity
干预措施: Placebo (Drug)
Drug: IX-01
Experimental
Two to four 200 mg capsules administered orally, 1-6 hours prior to sexual activity
干预措施: IX-01 (Drug)
结局指标
主要结局
Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)
时间窗: Last 4 weeks of treatment compared to baseline
IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred
次要结局
- Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale(Baseline to the end of treatment (approximately 8 weeks))
- Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure(Baseline to 8 weeks)
- Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire(Baseline to 8 weeks)
- Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)(Last 4 weeks of treatment compared to baseline)
- Mean Change in Score on Ejaculation-related Personal Distress(Last 4 weeks of treatment compared to baseline)
- Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire(Baseline to 8 weeks)
- Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)(Last 4 weeks of treatment compared to baseline)
- Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire(Baseline to 8 weeks)
- Mean Change in Score on Control of Timing of Ejaculation(Last 4 weeks of treatment compared to baseline)
- Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment(Baseline to last 4 weeks on treatment)
- Incidence of Treatment-emergent Adverse Events(Start of Treatment to end of study (approximately 10 weeks))
- Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire(Baseline to 8 weeks)
研究者
研究点 (10)
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