B/106, Priya Apartments, Main Carter Road, ,Opp Vyas Chemist, Borivali (E)-400066 Mumbai MAHARASHTRA
Dr. Rajesh Goyal, MD
Tan-Man Clinic
33/3 Shakti Nagar,,-110007 New Delhi DELHI
drrajeshgoyal_2002@yahoo.com
Details of Ethics Committee
No of Ethics Committees= 24
Name of Committee
Approval Status
Abhaya Ethics Committee for Dr. Anjanappa Jagadish
Approved
Dr. Babasaheb Ambedkar Medical Research Society's Ethics Committee for Dr. Sanjeev Saoji
Approved
Ethics Committee M.S. Chellamuthu Trust and Research Foundation for Dr. C. Ramasubramanian
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Abhay Paliwal
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Arun Marwale
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Dinesh V. Tembe
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Hemang Desai
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Kausar Abbasi
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Ketan Parmar
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Milind Bapat
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Mrugesh Vaishnav
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. P. N. Suresh Kumar
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Pratap V. Panhale
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Rajan B. Bhonsle
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Rajesh Goyal
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Rohan Kusumgar
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Sanjay Phadke
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Sundeep Jadhav
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Ujwal Sardesai
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Umesh Nagapurkar
Approved
Independent Ethics Committee, Dhanashree Hospital for Dr. Vilas Bhailume
Approved
O & P Institutional Ethics committee for Dr. Avavinash Phadnis
Approved
Sahyadri Clinical Research and Development Center Ethics committee for Dr. Ketan Pai
Approved
Spandana Ethics Committee for Dr. Mahesh Gowda
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Premature Ejaculation,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Dapoxetine Hydrochloride
One tablet,to be taken approximately 1 to 3 hours prior to sexual activity for 8 weeks
Comparator Agent
Placebo
One tablet,to be taken approximately 1 to 3 hours prior to sexual activity for 8 weeks
Inclusion Criteria
Age From
Age To
Gender
Details
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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Responder rate
4 weeks and 8 weeks
Secondary Outcome
Outcome
TimePoints
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
Baseline, 4 weeks and 8 weeks
Target Sample Size
Total Sample Size="172" Sample Size from India="" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
Date Missing
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
24/06/2010
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="" Months="0" Days="0"
Recruitment Status of Trial (Global)
Completed
Recruitment Status of Trial (India)
Publication Details
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.