CTRI/2010/091/000660
Completed
Phase 3
Clinical study to evaluate efficacy and safety of Dapoxetine Hydrochloride Tablet in treatment of Premature Ejaculation.
Emcure Pharmaceuticals Ltd, Pune0 sites172 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Emcure Pharmaceuticals Ltd, Pune
- Enrollment
- 172
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \&\#8805; 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
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
Photodynamic diagnosis using 5-ALA for biliary pancreatic cancerBiliary pancreatic cancerJPRN-jRCTs061210042Isomoto Hajime62
Not yet recruiting
Not Applicable
Efficacy and safety of Photodynamic diagnosis using aminolaevulinic acid for oral cancer patients.JPRN-jRCTs031230192Satomura Kazuhito80
Unknown
Phase 3
Clinical trial of tablet containg two medicines - Dapoxetine and Sildenafil - for the treatment of co-existing Erectile Dysfunction and Premature Ejaculation.Health Condition 1: null- Co-existing Erectile Dysfunction and Premature EjaculationCTRI/2012/01/002370Emcure Pharmceuticals Ltd Pune200
Recruiting
Phase 2
Clinical study on Vimosa Softgel in vaginal dryness and vaginal prolapseCTRI/2024/05/067423Abhinav Health Care Products Pvt Ltd
Completed
Phase 3
Clinical Study to evaluate efficacy and safety of Eslicarbazepine acetate as an adjunctive therapy in partial-onset seizuresCTRI/2010/091/001194Emcure Pharmaceuticals Ltd., Pune200