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Both Silodosin 4 mg and Dapoxetine 60 mg significantly improved IELT and sexual function scores in primary PE patients. However, Silodosin exhibited a more favorable tolerability profile with fewer side effects, making it a safer, clinically effective alternative.
Dapoxetine 60 mg, the initial FDA-approved on-demand treatment for PE, which is a selective serotonin reuptake inhibitor (SSRI) . However, Silodosin 4 mg, an α1-adrenoceptor antagonist, has emerged as a promising alternative, particularly for patients dissatisfied with Dapoxetine . This investigation is designed to evaluate the efficacy and tolerability of Silodosin 4mg and Dapoxetine 60mg in the treatment of primary premature ejaculation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | sildosin 4mg |
|
| group B | Active Comparator | dapoxetine 60mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildosin 4mg | Drug | ondemand sildosin 4mg |
| |
| dapoxetine 60mg |
| Measure | Description | Time Frame |
|---|---|---|
| Intravaginal ejaculatory Latency time | changes in latency time | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| side effects | any side effects were recorded | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
male patients in heterosexual relation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha faculty of medicine, urology department | Banhā | Qalyubia Governorate | 13511 | Egypt |
it will be shared upon request
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2024 | Jul 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C080598 | dapoxetine |
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| Drug |
ondemand dapoxetine 60mg |
|
| D000091642 | Urogenital Diseases |
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |