Efficacy and safety of Dapoxetine Hydrochloride Tablet in treatment of Premature Ejaculation

Phase 3

• Conditions: Premature Ejaculation

• Registration Number: CTRI/2010/091/000660
• Lead Sponsor: Emcure Pharmaceuticals Ltd, Pune

Brief Summary

This Multicentric, double-blind, randomized, clinical trial will assess the effeicacy and safety of Dapoxetine in premature ejaculation. Patient satisfing inclusion/exclusiuon criteria will be randomized to receive Dapoxetine or placebo approximately 1 to 3 hours prior to sexual activity for 8 weeks. Subjects will be evaluated at baseline, after 4 and 8 weeks of therapy for efficacy and safety variables. Laboratory investigation will be done at baseline and after completion of therapy.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 172

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

• 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 antipsychotics8.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 hypotension12.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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responder rate	4 weeks and 8 weeks

Secondary Outcome Measures

Name	Time	Method
1.Patient reported outcome measures for premature ejaculation profile2.Clinical Global impression for change in premature ejaculation 3. Improvement in premature ejaculation (PE) score	Baseline, 4 weeks and 8 weeks

Trial Locations

Locations (24)

Aashray Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Abhaya Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Abhay Paliwal; 🇮🇳 Indore, MADHYA PRADESH, India

Dr. Hemang Desai; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. Pratap Panhale?s Clinic; 🇮🇳 Latur, MAHARASHTRA, India

Dr. Sanjay Phadke's Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Dr. Vilas Bhailume, MBBS; DPM; 🇮🇳 Pune, MAHARASHTRA, India

Heart to Heart Counselling Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

IQRAA International Hospital and Research Center; 🇮🇳 India

Jeswani Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

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Aashray Clinic

🇮🇳Ahmadabad, GUJARAT, India

Dr. Rohan D. Kusumgar, MD (Psy)

Principal investigator