A Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Efficacy of Promescent Lidocaine Spray in Men With Premature Ejaculation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intravaginal Ejaculatory Latency Time (IELT) in seconds
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of treatment with Promescent Lidocaine Spray compared with placebo in patients with premature ejaculation.
详细描述
Promescent Lidocaine Spray is a non-prescription drug that is marketed under an over-the-counter drug monograph (21 CFR Section 348.10 Subpart B (a)(2)) for male genital desensitizing drug products. In addition the evaluating the efficacy of treatment with Promescent, this study will evaluate patients' subjective distress, perception of improvement and optimal dose, and safety and tolerability of Promescent for patients with premature ejaculation and their respective partners.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has provided written informed consent before screening.
- •Subject is a male, 18 years of age or older.
- •Subject meets the diagnostic criteria for premature ejaculation as defined by the DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision; 2000).
- •Subject has a stable, monogamous, heterosexual relationship and sexually active for at least the last 6 months.
- •Subject and partner are willing and able to engage in sexual intercourse.
排除标准
- •Subject has never achieved an intravaginal ejaculation during the past 6 months (i.e., always ejaculates prior to penetration).
- •Subject has other forms of ejaculatory dysfunction (e.g., retrograde ejaculation, anejaculation, painful ejaculation).
- •In the opinion of the investigator, the subject has a condition or is in a situation that may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's ability to participate in the study.
研究组 & 干预措施
Promescent Lidocaine Spray
Double-Blind Treatment Period: 3 cycles (3 weeks each); 1 week wash-out between each cycle Open-Label Treatment Period: 4 cycles (1 week each); no wash-out
干预措施: Promescent Lidocaine Spray (Drug)
Placebo
Double-Blind Treatment Period: 3 cycles (3 weeks each); 1 week wash-out between each cycle Open-Label Treatment Period: 4 cycles (1 week each); no wash-out
干预措施: Placebo (Drug)
Placebo
Double-Blind Treatment Period: 3 cycles (3 weeks each); 1 week wash-out between each cycle Open-Label Treatment Period: 4 cycles (1 week each); no wash-out
干预措施: Promescent Lidocaine Spray (Drug)
结局指标
主要结局
Intravaginal Ejaculatory Latency Time (IELT) in seconds
时间窗: Week 11
The primary efficacy outcome is the proportion of subjects that achieve a mean IELT of greater than 90 seconds at Week 3, 7, and 11.
次要结局
- Adverse events/reactions to treatments(Week 11)
- Subjective distress(Week 3, 7, and 11)
- Perceived optimal dosage of treatment(Week 3, 7, and 11)
- Perception of improvement in premature ejaculation(Week 3, 7, and 11)
研究者
Eugene Y Rhee, MD
Chief, Department of Urologic Surgery
Kaiser Permanente