Clinical assessment of efficacy and safety of NRL/MW/201901 in patients suffering from erectile dysfunction- A Randomized, Double Blind, Placebo Controlled, Interventional, Prospective, Clinical Study.

etsurf Communications Pvt Ltd0 个研究点目标入组 105 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 105

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•Male subjects aged 21-50 years suffering from ED.
•Subjects who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit.
•Subjects should be in an active stable sexual relationship for the entire duration of study
•Subjects willing to participate in clinical trial and who have read understood and signed informed consent form.
•Subjects willing to make all required study visits

排除标准

•Subjects having anatomical abnormalities of the penis.
•Patients that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs.
•Subjects with severe form of sexual dysfunction as evidenced by at least one of the following conditions,
•-An International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is less than 11 and greater than 25 at screening
•-Subjects with prior ineffective treatment with (or non-responder to) any PDE5 Inhibitor or underwent treatment for promoting spermatogenic fertility in last 3 months
•-Subjects with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease
•-History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
•-Presence of any drug or therapy that may have relation with ED and sexual dysfunction (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc.)
•Subjects with history or presence of significant alcoholism or drug abuse within the past 1 year.
•Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion-
•a.cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders
•Subjects with history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products more than 10 times per day.
•Subjects with any clinically significant laboratory or ECG findings during screening.
•Patients receiving hormonal treatment, antidepressants, antipsychotics, or any other psychoactive drugs.
•Known cases of varicocele, hydrocele, HIV/AIDS, Hepatitis C and B, Cancer and major debilitating diseases as a clinical observation.
•Known hypersensitivity to ingredients used in study drugs
•Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol

研究者

发起方

etsurf Communications Pvt Ltd

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