Efficacy of Adding Sildenafil to Dapoxetine in Treatment of Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- intravaginal latency time changes IVLT
研究概览
简要总结
Study Design: Single Blind Placebo Controlled Randomized Trial, aiming to assess the efficacy and safety of adding sildinafile 50 mg to dapoxitine 30 mg in dapoxitine non responding premature ejaculation.
详细描述
Study Design: Single Blind, Placebo Controlled Randomized Trial.
Study Setting: Urology outpatient clinics at Al-Hussein and Sayed Galal Hospitals; Al-Azhar University; Cairo; Egypt.
Timeline: 12 months [8 months for data collection; 2 months for thesis writing and 2 months for publication].
Study Population:
- The study participants will be males suffering from primary or acquired mono-symptomatic premature ejaculation (PE) that did not respond to 2 months of dapoxetine monotherapy.
- participants will considered to have PE if they fulfilled the criteria of the International Society for Sexual Medicine that defines PE as a male sexual dysfunction characterized by (i) ejaculation which always or nearly always occurs prior to or within 1 min of vaginal penetration, either present from the first sexual experience or following a new bothersome change in ejaculatory latency. (ii) Negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy(Gillman & Gillman, 2019).
- Other patient inclusion criteria will be: age ≥20 years old, married and in a stable regular sexual relationship for at least 3 months before the study.
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
- Single (Participant)
盲法说明
participants of both groups will have no knowlage regarding the added medication they will recieve either sildinafile or placebo.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients, age ≥20 years old, married and/or in a stable regular sexual relationship for at least 3 months before the study.
排除标准
- •- Men with associated erectile dysfunction (ED).
- •Men with associated chronic prostatitis.
- •Diabetes Mellitus (DM).
- •Advanced renal or hepatic diseases.
- •Neurological diseases and C.N.S. medications.
研究组 & 干预措施
sofenacine recievers group A
Group (A) will receive sildenafil 50mg tablet form as additive therapy to dapoxetine 30 mg tablet form on demand for 8 weeks.
干预措施: Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tablet (Drug)
palcebo recievers group B
Group (B) will continue on dapoxetine 30mg tablet form with placebo tablet form of the same shap and colour of sildinafile on demand for 8 weeks.
干预措施: Placebo oral tablet and Dapoxitine 3mg Oral tablet (Drug)
结局指标
主要结局
intravaginal latency time changes IVLT
时间窗: Eight weaks for each participant of both groups
Using PEDT premature ejaculation diagnostic tool (PEDT)
overall partner satisfaction
时间窗: Eight weaks for each participants of both groups
using Sexual Satisfaction Index (SSI).
次要结局
未报告次要终点
研究者
Mohamed Ibrahim Almetwally Algammal,MD
Clinical professor
Al-Azhar University