An open label, interventional, multi-center, prospective clinical study to evaluate efficacy and safety of ‘IMPERIM® Capsules’ in patients suffering from mild to moderate erectile dysfunction
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- 1.Assessment of erectile function of penis on Erectile function subscale of IIEF Questionnaire
研究概览
简要总结
Itis an open label, interventional, multi-center, prospective clinical study toevaluate efficacy and safety of ‘IMPERIM® Capsules’ in patients suffering frommild to moderate erectile dysfunction. The study will conducted at three sitesin India. Subjects will be advised to consume 2 IMPERIM® capsules twice dailyorally after meals with water for 30 days. The primary objectives of the studywill be to assess erectile function ofpenis on Erectile function subscale of IIEF Questionnaire and hardness of penison Erection Hardness Score (EHS). The secondary objectives of the study will beto assess sexualdesire or libido and other parameters on IIEF questionnaire, male sexual health on EDITS questionnaire(Patient & Partner version), quality of Sexual life on Sexual Quality ofLife Questionnaire (SQoL-M), changes in serum testosterone levels (Free andTotal), drug compliance, global assessment for overall change by investigatorand patient and tolerability of study drug by assessing adverse events and laboratoryparameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Subjects who have scored 13 to 24 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening.
- •2.Subject without any organic cause of Erectile Dysfunction.
- •3.Subjects should be in an active stable sexual relationship for the duration of study 4.Subject willing to participate in clinical trial and who have read, understood and signed informed consent form 5.Subjects willing to make all required study visits 6.Subjects willing to follow study instructions given by the investigator.
排除标准
- •1.Subjects with major illnesses and sexual dysfunction due to anatomical surgical or pharmacological causes 2.History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity 3.Presence of any drug or therapy that may have relation with ED and sexual dysfunction 4.Subjects with total erectile failure or any other sexual disorder, hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie disease or penile trauma
- •Subjects with preexisting systemic disease necessitating long-term medications 6.Continuing history of alcohol and or drug abuse 7.Subjects with significant abnormal laboratory parameters.
结局指标
主要结局
1.Assessment of erectile function of penis on Erectile function subscale of IIEF Questionnaire
时间窗: Day -3, Day 0, Day 15, Day 30
2.Hardness of penis on Erection Hardness Score (EHS)
时间窗: Day -3, Day 0, Day 15, Day 30
次要结局
- 1.Assessment of Sexual desire or Libido and other parameters on IIEF(2.Assessment of Male sexual health on EDITS questionnaire)