Evaluation of efficacy and safety of SHL 1046 in patients suffering from erectile dysfunction- A Randomized, Double Blind, Placebo Controlled, Multi-centric, Interventional, Prospective, Clinical Study. - NI

Savesta Lifesciences Inc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male subjects aged 21-50 years suffering from ED.
•2.Subjects who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit.
•3.Subjects should be in an active stable sexual relationship for the entire duration of study
•4.Subjects 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

•1.Subjects having anatomical abnormalities of the penis.
•2.Patients that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs.
•3.Subjects with severe form of sexual dysfunction
•4.Subjects with history or presence of significant alcoholism or drug abuse within the past 1 year.
•5.Subjects with any clinically significant laboratory or ECG findings during screening.
•6.Patients receiving hormonal treatment, antidepressants, antipsychotics, or any other psychoactive drugs.
•7.Known cases of varicocele, hydrocele, HIV, AIDS, Hepatitis C and B, Cancer and major debilitating diseases
•8.Known hypersensitivity to ingredients used in study drugs
•9.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

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