A Open label Clinical end point study to evaluate the Efficacy and Safety of NATURAL DELAY SPRAY in Male Patients With Premature Ejaculation
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- 1. Intravaginal ejaculation latency time (IELT)
研究概览
简要总结
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study.
25 subjects diagnosed with Premature Ejaculation and satisfying selection criteria, will be enrolled in the study in a single group.
Test Group– NATUREASE SPRAY: 25 subjects : For 4 weeks. Massage 2-6 sprays into the head and shaft of the penis depending on your sensitivity. Apply minimum of ten minutes before intercourse over a period of 4 weeks as per requirement.
Subjects will be asked to visit clinical facility/institution for their follow up at week, 2 and 4 weeks for assessment of outcome parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Informed consent for subjects and partners 2.Men 20-60 years of age 3.Stable monogamous relation at least for 6 months 4.Premature Ejaculation Diagnosis Tool (PEDT) score of less than
- •5.At least 6 months of premature ejaculation History 6.IELT (Intravaginal ejaculation latency time) of 2 min and more than 75% of evaluable events during 4 week screening period.
排除标准
- •1.History of medical or psychiatric illness 2.Erectile dysfunction (21 International Index of Erectile Function-Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction 3.Partner sexual dysfunction 4.Known hypersensitivity to the ingredients of the test product.
- •5.Any known, clinically significant, systemic disease in addition to the trial indication that might negatively impact the study outcome.
- •6.History of drug or alcohol abuse during the last 3 months.
结局指标
主要结局
1. Intravaginal ejaculation latency time (IELT)
时间窗: Baseline and 4 weeks
2. Sexual satisfaction will be assessed using a Likert scale.
时间窗: Baseline and 4 weeks
3. PEDT and AIPE score before and after the treatment of 4 weeks.
时间窗: Baseline and 4 weeks
次要结局
- Clinical safety assessments, including weight, blood pressure, pulse and adverse events(Baseline and 4 weeks)