Back to resultsEvaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation (PE)
Primary Purpose
Premature Ejaculation
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Multi-Vitamin Tablets
Dapoxetine
Dapoxetine and folic acid.
Dapoxetine and vitamin B12
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ejaculation focused on measuring Premature Ejaculation
Eligibility Criteria
Inclusion Criteria:
Premature ejaculation
Exclusion Criteria:
- Erectile dysfunction
- Diabetes mellitus
- chronic prostatitis
- Advanced renal or hepatic diseases
- Neurological diseases
Sites / Locations
- Faculty of Medicine, Sohag University, Egypt
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Dapoxetine
Dapoxetine and folic acid.
Dapoxetine and vitamin B12
Arm Description
Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.
Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
Outcomes
Primary Outcome Measures
Arabic Index of Premature Ejaculation
The AIPE questionnaire includes seven questions.Response to each question will be scored on a scale from 1 to 5.
Intravaginal ejaculatory latency times
By using stopwatches
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04085354
Brief Title
Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation
Acronym
PE
Official Title
Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation: A Randomized Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
August 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will aim to assess of the clinical efficacy and safety of dapoxetine, combined dapoxetine with folic acid and combined dapoxetine with vitamin B12 in treatment of patients with premature ejaculation: A randomized placebo-controlled clinical trial.
Detailed Description
In a single-blind placebo-controlled clinical study, it will be carried out on 120 patients with PE.
All patients will be randomized equally divided into four groups (30 patients each).
Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
Premature Ejaculation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
All patients will be randomized equally divided into four groups (30 patients each).
Masking
InvestigatorOutcomes Assessor
Masking Description
The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
Arm Title
Dapoxetine
Arm Type
Active Comparator
Arm Description
Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.
Arm Title
Dapoxetine and folic acid.
Arm Type
Active Comparator
Arm Description
Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
Arm Title
Dapoxetine and vitamin B12
Arm Type
Active Comparator
Arm Description
Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
Intervention Type
Drug
Intervention Name(s)
Multi-Vitamin Tablets
Intervention Description
The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
Intervention Type
Drug
Intervention Name(s)
Dapoxetine
Intervention Description
The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.
Intervention Type
Drug
Intervention Name(s)
Dapoxetine and folic acid.
Intervention Description
The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
Intervention Type
Drug
Intervention Name(s)
Dapoxetine and vitamin B12
Intervention Description
The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
Primary Outcome Measure Information:
Title
Arabic Index of Premature Ejaculation
Description
The AIPE questionnaire includes seven questions.Response to each question will be scored on a scale from 1 to 5.
Time Frame
0-6 weeks after treatment
Title
Intravaginal ejaculatory latency times
Description
By using stopwatches
Time Frame
0-6 weeks after treatment
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premature ejaculation
Exclusion Criteria:
Erectile dysfunction
Diabetes mellitus
chronic prostatitis
Advanced renal or hepatic diseases
Neurological diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Abu El-Hamd, MD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Sohag University, Egypt
City
Sohag
ZIP/Postal Code
82524
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation
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