Health Condition 1: null- Co-existing Erectile Dysfunction and Premature Ejaculation
Conditions
Interventions
Intervention1: Fixed dose combination of Dapoxetine Hydrochloride 30 mg and Sildenafil Citrate 50 mg Tablet: One tablet of Fixed Dose Combination is to be taken approximately 1 hour prior to sexual ac
Sponsors
Emcure Pharmceuticals 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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rateTimepoint: After 2 weeks and 4 weeks of treatment | — |
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) score 4) Improvement in International Index of Erectile Function (IIEF) 5) Improvement in Sexual Health Inventory for Male (SHIM) 6) Improvement in qualitative scale for subjective assessment of Erectile Response published 7) Clinical Global impression for change in erectile dysfunctionTimepoint: At baseline, after 2 and 4 weeks of therapy;8) Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator 9) Subjectâ??s global assessment about the tolerability of the drug 10)Physicianâ??s global assessment about the tolerability of the drug 11) Lab reports & ECG to evaluate any deviation from normal valuesTimepoint: At baseline, after 2 & 4 weeks of therapy | — |
Countries
India
Contacts
Public ContactDr Anand V Tendulkar
Emcure Pharmaceuticals Ltd,
Outcome results
None listed