Premature Ejaculation
Conditions
Keywords
Premature Ejaculation
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
Interventions
DRUGMulti-Vitamin Tablets
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.
DRUGDapoxetine
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.
DRUGDapoxetine and folic acid.
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.
DRUGDapoxetine and vitamin B12
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
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes 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.
Intervention model description
All patients will be randomized equally divided into four groups (30 patients each).
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Premature ejaculation
Exclusion criteria
* Erectile dysfunction * Diabetes mellitus * chronic prostatitis * Advanced renal or hepatic diseases * Neurological diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arabic Index of Premature Ejaculation | 0-6 weeks after treatment | The AIPE questionnaire includes seven questions.Response to each question will be scored on a scale from 1 to 5. |
| Intravaginal ejaculatory latency times | 0-6 weeks after treatment | By using stopwatches |
Countries
Egypt
Outcome results
None listed