CTRI/2010/091/001118已完成3 期
A randomized, double blind, placebo controlled, cross over, multicentric study to assess the efficacy and safety of Dapoxetine tablets in patients suffering from premature ejaculation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male patients of 18 to 60 years of age.
- •2.Stable, monogamous sexual relationship with a female partner
- •3.Established diagnosis of premature ejaculation (PE)
- •4.Informed consent
排除标准
- •1.Erectile dysfunction or other forms of sexual dysfunction.
- •2.Patients whose partners have problems of self-reported sexual dysfunction.
- •3.History of major psychiatric disorder.
- •4.Other significant pathological cardiac conditions
- •5.Concomitant treatment which is not permissible
- •6.History of orthostatic hypotension, seizures, lactose intolerance, hepatic or renal impairment.
- •7.Patients with known hypersensitivity to SSRIs.
- •8.Patients with any other serious concurrent illness or malignancy.
- •9.Patients with continuing history of alcohol and / or drug abuse.
- •10.Participation in another clinical trial in the past 3 months.
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