Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 6:21 AM
Study NCT ID:
NCT07081659
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
On-demand Silodosin 4mg vs Dapoxetine 60mg in Treatment of Primary Premature Ejaculation
Sponsor:
Benha University
Organization:
Study Overview
Official Title:
On-demand Silodosin 4mg vs Dapoxetine 60mg in the Treatment of Primary Premature Ejaculation
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: