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临床试验/NCT02581826
NCT02581826Unknown2 期

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
40
试验地点
1
主要终点
Intravaginal Ejaculatory Latency Time (IELT)

研究概览

简要总结

The objectives of the present study aims to evaluate the safety and efficacy of Silodosin in a population of patients wih Premature Ejaculation (PE). Coupled with efficient diagnosis, it is hoped that the newer agent will improve the quality of life for patients who suffer from Premature Ejaculation (PE).

详细描述

Premature Ejaculation (PE) is characterized as the most common sexual dysfunction in men with a prevalence of 21-33%. Based on the main theories about the pathophysiology of Premature Ejaculation (PE), the most commonly prescribed medications are topical anesthetics and serotonin-specific reuptake inhibitors (SSRIs). It has been reported that the abnormal ejaculation of semen is a typical but rather infrequent side effect of some α1-adrenoceptor antagonists. Silodosin had the highest selectivity for the vas deferens compared with other α1-adrenoceptor antagonists.

Patients suitable for inclusion in the baseline period were those who (as part of the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire) rated their perceived control over ejaculation as 'moderately difficult', 'very difficult' or 'extremely difficult', and the other four items as 'about half the time', 'more than half the time' or 'almost always or always'. Patients completed the Index of Premature Ejaculation (IPE) and Premature Ejaculation Profile (PEP) questionnaires, and rated the quality of their orgasm in response to the question: 'In general, how do you rate the orgasm you experience during sexual intercourse?' on a 5-point scale ('very poor', 'poor', 'satisfactory', 'good', 'very good'). Patients with a baseline Intravaginal Ejaculation Latency Time (IELT) of 2 minutes or less, as measured by a partner-held stopwatch, for at least two of the first three sexual encounters were eligible for randomization into the double-blind phase. In total of 40 eligible patients were randomized to receive double-blind treatment with 4 mg Silodosin or matched placebo for 3 months. One dose was to be taken 2 hours before anticipated sexual intercourse, and only one dose was allowed per 24-h period. Ejaculation-delaying techniques and behavioural therapy were to be avoided. Couples were instructed to attempt sexual intercourse four or more times per month during the 12-week treatment period (minimum of 24 h between doses of medication). During each sexual encounter, the Intravaginal Ejaculation Latency Time (IELT) was measured and recorded, together with efficacy and tolerability data. Ejaculation occurring before penetration was assigned an Intravaginal Ejaculation Latency Time (IELT) of 0 minute. The time noted on the stopwatch at this point was recorded as the duration of sexual intercourse until ejaculation or withdrawal. Patients returned to the clinic at 14-21 days intervals (visits 1, 2, 3, 4, 5 and 6) at which the Index of Premature Ejaculation (IPE) and Premature Ejaculation Profile (PEP) questionnaires were completed. Also, at visit 3 and 6 patients had a safety evaluation and rated the quality of their orgasms. Patients' satisfaction for the treatment was evaluated by Clinical Global Impression of Change (CGIC) in Premature Ejaculation (PE).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Premature Ejaculation (PE) diagnosed by Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) criteria.
  • Stable heterosexual, monogamous relationships more than 3 months.
  • Age of 20 years or order.
  • Written informed consent.

排除标准

  • α1-adrenoceptor antagonists within 4 weeks.
  • Erectile dysfunction (ED) defined by an Index of Erectile Function (IIEF-5) score <
  • History of physical or psychological disorder (patient or partner).
  • Patient need to adjust dosage during the screening and treatment period, including tricyclic antidepressants, monoamine oxidase inhibitors or selective serotonin reuptake inhibitors (SSRIs).
  • Antidepressant therapy, local anaesthetic spray, intracavernosal injection or psychotherapy within 4 weeks.
  • History of alcohol or drug abuse.
  • Pregnant partners.

研究组 & 干预措施

Silodosin

Active Comparator
  1. Silodosin capsules of 4 mg, oral: 4 mg once daily with a meal, total dosage 12 mg for 14-21 days.
  2. This arm received Silodosin in the first intervention period and Placebo in the second period (after washout period of 14-21 days).
  3. The patients received 4 mg of Silodosin 1 times a day, total dosage 12 mg for 14-21 days.

干预措施: Silodosin (Drug)

Placebo

Placebo Comparator
  1. Placebo capsules of 4 mg, oral: 4 mg once daily with a meal, total dosage 12 mg for 14-21 days.
  2. This arm received Placebo in the first period and Silodosin in the second period (after washout period of 14-21 days).
  3. The patients received 4 mg of Placebo 1 times a day, total dosage 12 mg for 14-21 days.

干预措施: Placebo (Drug)

结局指标

主要结局

Intravaginal Ejaculatory Latency Time (IELT)

时间窗: up to 12 weeks

次要结局

  • Erectile function domain of the International Index of Erectile Function (IIEF)(Baseline)
  • Index of Premature Ejaculation (IPE)(up to 12 weeks)
  • Premature Ejaculation Profile (PEP)(up to 12 weeks)
  • Premature Ejaculation Diagnostic Tool (PEDT)(Baseline)
  • Clinical Global Impression of Change (CGIC)(up to 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheng-Hsing Hsieh

Cheng-Hsing Hsieh

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

研究点 (1)

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