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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Drug: Multi-Vitamin Tablets
* Drug: Dapoxetine
* Drug: Dapoxetine and folic acid.
* Drug: Dapoxetine and vitamin B12


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premature ejaculation Exclusion Criteria: Erectile dysfunction Diabetes mellitus chronic prostatitis Advanced renal or hepatic diseases Neurological diseases

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients will be randomized equally divided into four groups (30 patients each).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. | Drug: Multi-Vitamin Tablets<br>* 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.<br>|
| Active Comparator: Dapoxetine<br>Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. | Drug: Dapoxetine<br>* 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.<br>|
| Active Comparator: Dapoxetine and folic acid.<br>Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid. | Drug: Dapoxetine and folic acid.<br>* 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.<br>|
| Active Comparator: Dapoxetine and vitamin B12<br>Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12 | Drug: Dapoxetine and vitamin B12<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-6 weeks after treatment | 
| Intravaginal ejaculatory latency times | By using stopwatches | 0-6 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Ejaculation