CTRI/2010/091/001089尚未招募3 期
Evaluation of efficacy and safety of Dapoxetine versus placebo in the treatment of premature ejaculation: a randomized, double-blind, placebo-controlled, crossover, multi-centre study.
Sun Pharmaceutical Industries Ltd.Acme Plaza, Andheri Kurla Road, Andheri East,Mumbai ? 400059. Maharashtra. India.0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 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 aged between 21 and 64 years.
- •2.Patients are in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study.
- •3.Diagnosis of PE according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) for at least 6 months before study initiation.
- •4.Patients with willingness for minimum 2 sexual intercourse in a week.
- •5.Patients willing to give consent for participation in the study
排除标准
- •1.Patients with erectile dysfunction or other forms of sexual dysfunction and or partner sexual dysfunction.
- •2.Patients who are using SSRIs or tricyclic antidepressant as concomitant medication.
- •3.Patients with history of mania, hypomania or bipolar disorder.
- •4.Patients with uncontrolled hypertension or cardiac impairment.
- •5.Patients with epilepsy.
- •6.Patients who are using other forms of therapy for premature ejaculation (pharmacological or behavioral).
- •7.Patients taken Dapoxetine or participated in another study investigating pharmacologic treatment of PE.
- •8.Alcoholic patients.
- •9.Patients with known allergy or hypersensitivity to SSRIs or SNRIs.
- •10.Patients with history of malignancy.
- •11.Patients with moderate to severe liver problem.
- •12.Patients with moderate to severe hepatic impairment.
- •13.Patients with orthostatic hypotension.
- •14.Patients whose partners had problems with self-reported female sexual dysfunction.
- •15.Patients using recreational drugs with serotonergic activity such as ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD).
- •16.Patients whose treatment for ongoing depression or anxiety is discontinued, in order to initiate Dapoxetine for the treatment of PE.
- •17.Patients with bleeding or coagulation disorders.
- •18.Patients with severe renal impairment.
- •19.Patients on CNS active medicinal products.
- •20.Patients taking PDE5 inhibitors like tadalafil and sildenafil.
- •21.Patients who use alpha adrenergic receptor antagonists.
- •22Patients taking warfarin chronically.
- •23.Patients using following medication as concomitant medication or discontinued such medication within 7 days of screening:
- •?MAOIs, Thioridazine, SSRIs, SNRIs, TCAs, Phenothiazine, acetylsalicylic acid, NSAIDs, antiplatelet agents or anticoagulant (e.g., Warfarin)
- •?Herbal products with serotonergic effects (e.g. tryptophan, triptans, tramadol, linezolid, lithium, St. John?s Wort (Hypericum perforatum).
- •?Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, aquinavir, telithromycin, nefazadone, nelfinavir, atazanavir
研究者
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