NCT01024491已完成3 期
A Parallel Randomized Double Blind Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Paroxetine Daily Doses of 15 mg and 20 mg in the Treatment of Premature Ejaculation
MorePharma Corporation2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Intravaginal Ejaculatory Latency Time (IELT)
研究概览
简要总结
As study to investigate the efficacy and safety of daily doses of paroxetine of 15 and 20 mg for the treatment of premature ejaculation
详细描述
Randomized, double blind, placebo controlled, prospective and parallel trial. Men with premature ejaculation using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for at least 6 months, with an intravaginal ejaculatory latency time (IELT) ≤ 3 minutes. Three treatments are to be compared: placebo, 15 mg or 20 mg paroxetine for 12 weeks.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men between 20 and 70 years of age
- •with a stable relationship with a female partner
- •with the intention to continue with the same partner for the duration of the study
- •with diagnosis of premature ejaculation according to the criteria established in the Diagnostic and Statistical Manual of Mental Disorders IV edition, Revised Text for at least 6 months before inclusion
- •with an Intravaginal Ejaculatory Latency Time (IELT) ≤ 3 minutes in at least 75 % of a minimum of three sexual encounters, elapsing between them at least 18 hours during the selection phase of the study
- •with agreement to avoid pregnancy or planned surgery during the study,
- •female participants should not be pregnant at the inclusion
- •both male and female partners had to agree to participate and to sign the informed consent form
排除标准
- •any medical or surgical condition that could be associated with the initiation of premature ejaculation for secondary PE
- •history of myocardial infarction or stroke in the last 6 months
- •hemorrhagic disorder, hepatitis B or C, HIV infection, penile implant surgery at any time
- •alcohol or drug abuse in the last 2 years
- •any medical or psychiatric condition that could interfere with study procedures and evaluations
- •uncontrolled diabetes
- •hypotension (defined as systolic/diastolic blood pressure < 90/50 mm Hg)
- •uncontrolled hypertension
- •diagnosis of erectile dysfunction or a score ≤ 21 in the erectile function domain of the International Index of Erectile Function (IIEF) at inclusion
- •treatment with any investigational drug in the last month or 5 times the half life of the drug
- •use of medications that could enhance the effect of paroxetine,
- •known intolerance to selective serotonin recapture inhibitors
- •hypoactive sexual desire not caused by PE
- •sexual dysfunction in the female partner that could interfere with participation
- •any other significant clinical conditions that could interfere with study procedures
- •employees of research sites and relatives of researchers
研究组 & 干预措施
paroxetine 15mg
Experimental
Active treatment with daily dose of paroxetine 15mg.
干预措施: paroxetine (Drug)
paroxetine 20 mg
Experimental
Active treatment daily dose of paroxetine 20 mg
干预措施: paroxetine (Drug)
placebo
Experimental
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Intravaginal Ejaculatory Latency Time (IELT)
时间窗: Visit 2 Baseline, Visit 3 and Visit end of treatment, at 2, 6 and 12 weeks after entry to study respectively
次要结局
- Score of the control domain of the Index of Premature Ejaculation(Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively)
- Score of the distress with ejaculation domain of the Index of Premature Ejaculation(Visit 1 Screning, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively)
- Score of the sexual satisfaction domain of the Index of Premature Ejaculation(Visit 1 Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively)
- Erectile function domain of the International Index of Erectile Function(Visit 1 Screening, Visit 2 Baseline, Visit 3 and Viit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively)
- Sexual desire domain of the International Index of Erectile Function(Visit 1 Screening,Visit 2 Baseline,Visit 3 and Visit 4 end of treatment, Visit 1, Screening, Visit 2 Baseline, Visit 3 and Visit 4 end of treatment, at entry , 2, 6 and 12 weeks after entry to study, respectively)
研究者
研究点 (2)
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