A Randomized, Double-Blinded, Placebo-Controlled, Observational Pilot Study to assess the Safety and Efficacy of Stay-On oral liquid for prospective sexual function

SHREE MARUTI HERBA0 个研究点目标入组 26 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 married patients aging 21 â?? 55 years
•2.The patients who have erectile insufficiency, premature ejaculation or lower sex drive for at least 3 month.
•3.Subjects with controlled diabetes mellitus and/or hypertension on monotherapy or low dose combination therapy (accepted co-medication in obese and overweight subjects, for example, antidiabetic drug metformin and hypertension, for example, antihypertensive drug amlodipine, atenolol, perindopril).
•4.The subjects should be sexually active and in a monogamous relationship with their heterosexual partner. Men must be sexually active: A man is considered sexually active if he has been engaged in sexual activity with a partner during the past 4 weeks (at least once) and plans to be active until end of study (unless due to travel or other practical reasons).
•5.Erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire <= 18.
•6.Fluent and literate in local language with the ability to read, comprehend and record information on the IIEF-15 questionnaire.
•7.Able to swallow and retain oral medication.
•8.Cooperative and understanding skills.
•9.Patient willing to provide written informed consent.
•10.Patient willing to give specimen of semen
•11.Patients ready to abstain from using any drug other than Investigational Product for the treatment of the studied condition, except in emergencies, in which case the responsible party must be immediately notified.

•1.History or evidence of prostate cancer
•2.Current or prior use of any drugs with anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents) within the 6 months prior to visit 1 (screening).
•3.Current or 1 month prior use of PDE-5 inhibitors for Erectile Dysfunction, Anabolic steroids, Use of phyto-therapy for sexual dysfunction within 2 weeks prior to screening visit.
•4.Any recent major surgical procedures.
•5.Spinal cord injury
•6.Radical prostatectomy
•7.Radical pelvic surgery

发起方

SHREE MARUTI HERBA