CTRI/2010/091/000660已完成3 期
Clinical study to evaluate efficacy and safety of Dapoxetine Hydrochloride Tablet in treatment of Premature Ejaculation.
Emcure Pharmaceuticals Ltd, Pune0 个研究点目标入组 172 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
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 subjects between 18 to 64 years of age.
- •2.Male subjects with stable, monogamous, heterosexual relationship with same woman for at least 6 months and expected/planned to maintain this relationship for duration of study.
- •3.Subjects meeting with diagnostic criteria for premature ejaculation (PE score ≥ 11) as specified in article published in European Urology 2007, 52: 565 ? 573.
- •4.Subject and his partner agreeing to attempt sexual intercourse 2 times/ week.
- •5.Subject willing to give written informed consent and willing to comply with trial protocol.
排除标准
- •1.Previous events or other conditions associated with premature ejaculation including but not limited to spinal trauma or pelvic surgery.
- •2.Subjects with premature ejaculation due medication withdrawal.
- •3.Erectile dysfunction or any other sexual dysfunction except premature ejaculation.
- •4.Sexual dysfunction in female partner, painful intercourse, partners with decreased interest in intercourse or other forms of sexual dysfunction.
- •5.Subjects with major psychiatric illness or previous suicidal attempts.
- •6.Subjects with history of epilepsy.
- •7.Subjects taking concurrent drug therapies OR within last 14 days of discontinuing treatment with : Monoamine oxidase inhibitor (MAOIs), Thioridazine, Selective serotonin reuptake inhibitor (SSRI), selective-norepinephrine reuptake inhibitor (SNRI), serotonergic medicinal/herbal products, tricyclic antidepressants, and atypical antipsychotics
- •8.Subjects taking concurrent treatment of: ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem, any vasodilators, antiplatelet, anticoagulants, PDE5 inhibitors, alcohol and any other recreational drug.
- •9.Use of other form of therapy (Pharmacological/ Behavioral) for premature ejaculation.
- •10.Patients with significant hematological/metabolic/endocrinologial (excluding type 2 Diabetes Mellitus) /respiratory/cardiovascular/neurological/psychiatric /liver/kidney diseases
- •11.Uncontrolled Hypertension OR History of orthostatic hypotension
- •12.Known hypersensitivity to SSRI, SNRI, and any constituent of the Test formulation.
- •13.Subjects with cardiac arrhythmia or any abnormality on ECG.
- •14.Subjects with previous history of bone marrow depression.
- •15.Patients who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug.
- •16.Patients with Alcohol or drug abuse.
- •17.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
研究者
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