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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
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.
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.
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.
Faculty of Medicine, Sohag University, Egypt
Sohag, Egypt
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.
Time frame: 0-6 weeks after treatment
Intravaginal ejaculatory latency times
By using stopwatches
Time frame: 0-6 weeks after treatment
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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