Evaluation of efficacy and safety of â??SHL 1066â?? in patient with low sperm count - A randomized, multicenter, double blind, placebo controlled, 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)Sperm count 1 million to less than 15 million/ml with normal sperm morphology
•2)Subjects capable of giving written informed consent, which includes compliance with protocol.
•3)Agree not to use any other treatment for erectile dysfunction (ED).
•4)Willing to give specimen of semen before & at the end of the clinical trial

•1.Subjects having azoospermia, of aspermia, or necrospermia.
•2.Subjects with clinical diagnosis of Varicocele & Hydrocele
•3.Subjects with history of undescended testis
•4.Subjects with inguinal hernia or other clinical condition on physical examination which may have relation to low sperm count
•5.Subjects with accessory gland infection
•6.Subjects with severe form of sexual dysfunction
•7.Subjects with history or presence of significant alcoholism or drug abuse within the past 1 year.
•8.Subjects with any clinically significant laboratory or ECG findings during screening.
•9.Subjects who underwent surgery within last 4 weeks or planned major surgery within next 3 months from the date of screening.
•10.Subjects who have participated in any drug research study within past 3 months.
•11.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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