CTRI/2012/01/002370Not Applicable3 期
Clinical study to evaluate efficacy and safety of Fixed Dose Combination of Dapoxetine Hydrochloride and Sildenafil Citrate Tablet in treatment of co-existing Erectile Dysfunction and Premature Ejaculation. - DAP-SI
Emcure Pharmceuticals Ltd Pune0 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
- Not Applicable
- 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 subjects between 18 to 64 years of age.
- •2.Male subjects with stable, monogamous, heterosexual relationship for at least 6 months and expected/planned to maintain this relationship for duration of study.
- •3.Subjects meeting with diagnostic criteria for erectile dysfunction (as per the international index of erectile function (IIEF) score lesser than or equal to 25; as specified in Urology 1999, 54: 346-351).
- •4.Subjects meeting with diagnostic criteria for premature ejaculation (PE score greater than or equal to 11) as specified in article published in European Urology 2007, 52: 565-573.
- •5.Subject and his partner agreeing to attempt sexual intercourse 2 times/ week.
- •6.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/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 with erectile dysfunction or premature ejaculation due medication withdrawal.
- •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 with history of stroke, myocardial infraction, heart failure, unstable angina, life-threatening arrhythmia and hypotension with in past 6 months.
- •8.Subjects for whom sexual activity is inadvisable because of their underling disease status.
- •9.Subject is a known case of autonomic neuropathy, retinitis pigmentosa, bleeding disorders, sickle cell anemia and active peptic ulcer disease.
- •10.Subjects with significant and uncontrolled hematological/metabolic/ endocrinologial/respiratory/cardiovascular/neurological/psychiatric/liver/kidney diseases.
- •11.Subjects with resting hypotension (BP 90/50) or hypertension ( BP 170/110)
- •12.Subjects with history of hypersensitivity to SSRI, SNRI, phosphodiesterase inhibitors and constituent of test product.
- •13.Subjects with cardiac arrhythmia or any clinically significant abnormality on ECG.
- •14.Subjects with previous history of bone marrow depression.
- •15.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
- •16.Subjects taking concurrent treatment of: nitrates, alpha blockers, vosodilators, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, cimetidine, erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem, any vasodilators, antiplatelet, anticoagulants, dapoxetine, PDE5 inhibitors, alcohol and any other recreational drug.
- •17.Use of other form of therapy (Pharmacological/ Behavioral) for erectile dysfunction/ premature ejaculation.
- •18.Subjects 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.
- •19.Subjects with alcohol or drug abuse.
- •20.Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.
研究者
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