Evaluation of efficacy and safety of EL/ED/01 in healthy individuals having erectile dysfunction- A Randomized, Double Blind, Placebo Controlled, Multi-centric, Interventional, Prospective, Clinical Study - NI

Emil Pharmaceutical Industries Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年11月13日

试验速览

暂无简介。

•1. Healthy Subjects who have scored 22 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening.
•2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study

•1.Subjects with known 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, in the opinion of the investigator.
•3. Presence of any drug or therapy that may have relation with ED and sexual dysfunction
•4. Subjects with total erectile failure
•5. Subjects with known hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie disease or penile trauma
•6. Subjects with history of disorders that may cause priapism
•7. Subjects who are taking any medication for psychiatric disorder
•8. Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery
•9. Subjects with hypotension or hypertension, diabetes, hepatic impairment, renal impairment or hematological disorders
•10. Subjects with significant abnormal laboratory parameters
•11. Known cases of varicocele, hydrocele, HIV, AIDS, Hepatitis C and B, Cancer and major debilitating diseases
•12. Subject having known hypersensitivity to any ingredient of the study products.

发起方

Emil Pharmaceutical Industries Private Limited