A randomized, double blind, placebo control study to assess the efficacy and safety of OLNP-05 capsule versus placebo for the treatment of subjects with premature ejacuation

Olene Life Sciences Private Limited0 个研究点目标入组 60 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 years to <= 60 years at the time of informed consent
•2. Subject having a monogamous, heterosexual relationship and expected/planned to maintain this relationship for the duration of study
•3. Subjects having baseline Intravaginal Ejaculatory Latency Time (IELT) of <2 minutes
•4. Subjects meeting with diagnostic criteria for premature ejaculation (PEP score >=11)
•5. Subject and his partner agreeing to attempt sexual intercourse 2 times/ week and to use stopwatch during the intercourse
•6. Subject willing to give written informed consent and willing to comply with trial protocol

•1. Previous events or other conditions that may affect 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. Subjects for whom sexual activity is inadvisable because of their underlying disease status.
•4. Sexual dysfunction in female partner, painful intercourse, partners with decreased interest in intercourse or other forms of sexual dysfunction.
•5. Subjects with significant and uncontrolled hematological /metabolic/ endocrinologial/ respiratory/ cardiovascular/ neurological/psychiatric/liver/ gastrointestinal/kidney diseases or other significant pathological conditions which as judged by Invesutigator may affect subject participation in the study
•6. Any concomitant treatment which is not permissible
•7. Continuing history of alcohol and / or drug abuse
•8. Recent participation in another clinical trial or receive some other drug during the study besides that in the protocol that known to alter the pharmacokinetics/pharmacodynamic profile of the study drug.
•9. Subject having a known allergy to any of the ingredients of investigational prodcut
•10. Any other condition that in the opinion of the Investigator does not justify the subjectâ??s participation in the study.

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