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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. |
|
| Dapoxetine | Active Comparator | Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. |
|
| Dapoxetine and folic acid. | Active Comparator | Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid. |
|
| Dapoxetine and vitamin B12 | Active Comparator | Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Vitamin Tablets | Drug | 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. |
| 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 |
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Inclusion Criteria:
Premature ejaculation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed Abu El-Hamd, MD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Sohag University, Egypt | Sohag | 82524 | Egypt |
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All patients will be randomized equally divided into four groups (30 patients each).
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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.
| Dapoxetine | Drug | 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. |
|
| Dapoxetine and folic acid. | Drug | 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. |
|
| Dapoxetine and vitamin B12 | Drug | 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 |
|
| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C067316 | Geritol |
| C080598 | dapoxetine |
| D005492 | Folic Acid |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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