An Observational Study to Evaluate Intravaginal Ejaculatory Latency Time and Patient-Reported Outcomes in Men With and Without Premature Ejaculation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,115
- 主要终点
- Change in Intravaginal Ejaculatory Latency Time (IELT)
研究概览
简要总结
The purpose of the study is to characterize intravaginal ejaculatory latency time (time between the start of vaginal intercourse and the start of intravaginal ejaculation) in men with and without premature ejaculation (PE) and to assess the validity of patient-reported outcomes.
详细描述
This is a multinational, multicenter, observational study in men with and without PE. The study consists of three visits: one visit for screening and enrollment, and two visits for observation after 1 and 2 months (total duration of 8 weeks). No study treatment for PE is administered to patients during the course of the study. Patients and their partners are expected to attempt sexual intercourse at least 2 times a week during the 8-week study period and to use a stopwatch to record the intravaginal ejaculatory latency time (IELT) during intercourse. At visits during the observation period "patients" (and/or partners if partners are responsible for completing questionaires) also provide patient-reported outcomes (PROs) by answering several questionnaires that include the topics of control over ejaculation, satisfaction with sexual intercourse, personal distress, interpersonal difficulty, and self-esteem. The study will estimate the distribution of the average IELT values for men with PE and men without PE.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Must be in a stable, monogamous, sexual relationship with the same woman (18 years of age or older) for at least 6 months, who plan to maintain their relationship for the duration of the study
- •Must be in good general health
- •Patient and partner willing to avoid situations or activities that may have an effect on their sexual activity (eg, refrain from any preplanned surgery)
排除标准
- •Has history of drug abuse within the past 2 years
- •Has history of or current major psychiatric disorder such as mood disorders, anxiety disorders, schizophrenia, other psychotic disorders, or alcoholism
- •Must have erectile dysfunction
- •Patient who has decreased interest in sexual intercourse or has other forms of sexual dysfunction
- •Patient whose partner has decreased interest in sexual intercourse, painful intercourse, or other forms of female sexual dysfunction
- •Patient whose partner is more than 3 months pregnant
结局指标
主要结局
Change in Intravaginal Ejaculatory Latency Time (IELT)
时间窗: Day 1 to Week 8
Estimated distribution of the average IELT for both the premature ejaculation (PE) and non-PE populations will be calculated.
Change in Patient-Reported Outcomes (PRO)
时间窗: Week 4 and Week 8
Additional evidence of reliability and validity of PROs for patients with and without PE and their partners will be expolred. The PROs will include different parameters related to (control over ejaculation, satisfaction with sexual intercourse, personal distress, and interpersonal difficulty).
次要结局
- PROs and IELT as indicators to clasify PE status.(Up to Week 8)
- Association between intravaginal ejaculatory latency time (IELT) and patient reportedout comes (PROs)(Up to Week 8)
- Utility of the Male Sexual Function Scale and Ejaculation Questionnaires(Day 1)