A Phase-III, Multicentric, Randomized, Double Blind, Placebo-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of Sildenafil Citrate 50 mg plus Dapoxetine 60 mg Tablet and Sildenafil Citrate 100 mg plus Dapoxetine 60 mg Tablet in the treatment of co-existing Erectile Dysfunction and Premature Ejaculation.

Ajanta Pharma Ltd0 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

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•1.Male subjects between 21 to 64 years of age both inclusive.
•2.Subjects with known case of co-existing Erectile Dysfunction and Premature Ejaculation who are not on any of the treatment for this condition for last 7 days.
•3.Male subjects with stable, monogamous, heterosexual relationship for at least 6 months and expected/planned to maintain this relationship for duration of study.
•4.Penile Doppler standard systolic and diastolic velocity range for inclusions ( <25 cm/sec as definite arterial dysfunction and 25-30 cm/sec as borderline case.)
•5.Subjects meeting with diagnostic criteria for erectile dysfunction (as per the international index of erectile function (IIEF) score lesser than or equal to 21).
•6.Subjects meeting with diagnostic criteria for Premature Ejaculation (PE score greater than or equal to 11).
•7.Subjects with intravaginal ejaculatory latency time (IELT) of <= 2 minutes.
•8.Subject and his partner agreeing to attempt sexual intercourse at least 2 times/week.
•9.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.

•1.Previous events or other conditions associated with premature ejaculation/erectile dysfunction including but not limited to spinal trauma or pelvic surgery.
•2.Subjects with genital anatomical deformities including but not limited to penile deformities.
•3.Sexual dysfunction in female partner, painful intercourse, partners with decreased interest in intercourse or other forms of sexual dysfunction.
•4.Subjects with known case of psychiatric illness or previous suicidal attempts.
•5.Subjects with known case of Epileptic seizures.
•6.Subjects with known case of stroke, myocardial infarction, heart failure, unstable angina and cardiac arrhythmias.
•7.Subjects with abnormal Liver Function Test with (LFT) values more than 2.5 times the upper limit of normal.
•8.Subjects with abnormal eGFR ( <60 mL/min/1.73 m2) will be excluded from the study.
•9.Subjects with Type 1 Diabetes will be excluded from the study.
•10.Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1C value greater than 8 mmol/mol will be excluded from the study.

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