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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Change from baseline in Intravaginal Ejaculatory Latency Time (IELT)
研究概览
简要总结
Based on the findings from different Indian studies, commonly reported premature ejaculation in adult Indian males attending psychosexual clinics is 77.6% and studies conducted in the skin out-’patient department have also found 16.6% of patients suffering from premature ejaculation. So this randomized, double blind, placebo control, parallel group study is designed to access the efficacy and safety of OLNP-05 capsule for the treatment of premature ejaculation. OLNP-05 is a combination of four herbal extracts with syngergistic action in patients with premature ejaculation. The study composed of total four visits with approximate duration of 56 days. A total 60 subjects will be visited study site during screening visit (Day-7 to 00), randomization visit (Day 1), treatment visit (Day 28) and end of study visit (Day 56). After confirming the inclusion and exclusion criteria subject will be randomized to test group (OLNP-05 capsule) or control group (placebo).
The efficacy end point is focused to determine the effect of OLNP-05 and placebo on the basis of Intravaginal Ejaculatory Latency Time (IELT), premature ejaculation profile(PEp) score and Clinical Global impression- Improvement scale (CGI-I). The safety endpoints of the study includes the change in vital parameters, laboratory parameters and incidence of adverse events.
The pretended duration of the study is approximately 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male subjects, aged ≥ 21 years to ≤ 60 years at the time of informed consent
- •Subject having a monogamous, heterosexual relationship and expected/planned to maintain this relationship for the duration of study
- •Subjects having baseline Intravaginal Ejaculatory Latency Time (IELT) of <2 minutes
- •Subjects meeting with diagnostic criteria for premature ejaculation (PEP score ≥11)
- •Subject and his partner agreeing to attempt sexual intercourse 2 times/ week and to use stopwatch during the intercourse
- •Subject willing to give written informed consent and willing to comply with trial protocol.
排除标准
- •Previous events or other conditions that may affect premature ejaculation/erectile dysfunction, including but not limited to spinal trauma or pelvic surgery
- •Subjects with genital anatomical deformities including but not limited to penile deformities
- •Subjects for whom sexual activity is inadvisable because of their underlying disease status.
- •Sexual dysfunction in female partner, painful intercourse, partners with decreased interest in intercourse or other forms of sexual dysfunction.
- •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
- •Any concomitant treatment which is not permissible
- •Continuing history of alcohol and / or drug abuse
- •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.
- •Subject having a known allergy to any of the ingredients of investigational prodcut
- •Any other condition that in the opinion of the Investigator does not justify the subject’s participation in the study.
结局指标
主要结局
Mean Change from baseline in Intravaginal Ejaculatory Latency Time (IELT)
时间窗: Screening visit, Visit 3 (Day 28) and Visit 4 (Day 56)
次要结局
- Mean change in PEP Index score (Mean of all four measures)(Screening visit, Visit 3 (Day 28) and Visit 4 (Day 56))
- Clinical Global impression- Improvement from visit-3 to visit 4(Visit 3 (Day 28) and Visit 4 (Day 56))
- Mean change from baseline in Improvement in individual parameters of premature ejaculation profile (PEP) scores(Screening visit, Visit 3 (Day 28) and Visit 4 (Day 56))