None listed
Conditions
Interventions
Intervention1: Dapoxetine Hydrochloride: One tablet,to be taken approximately 1 to 3 hours prior to sexual activity for 8 weeks
Control Intervention1: Placebo: One tablet,to be taken approximately 1 t
Sponsors
Emcure Pharmaceuticals Ltd, Pune
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rateTimepoint: 4 weeks and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Patient reported outcome measures for premature ejaculation profile 2.Clinical Global impression for change in premature ejaculation 3. Improvement in premature ejaculation (PE) scoreTimepoint: Baseline, 4 weeks and 8 weeks | — |
Countries
India
Contacts
Public ContactDr. Onkar Swami
Emcure Pharmaceuticals Ltd
Outcome results
None listed