On-demand Silodosin 4mg vs Dapoxetine 60mg in Treatment of Primary Premature Ejaculation

Benha University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Premature (Early) Ejaculation

Treatments

Drug: sildosin 4mg

Drug: dapoxetine 60mg

Study type

Interventional

Funder types

Other

Identifiers

NCT07081659

Ms13-3-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

95 patients

Sex

Male

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Heterosexual male
Sexually active
Aged 25 to 65 years old.
Primary premature ejaculation (IELT < 1 minute)
They had experienced PE for a minimum of 6 months

Exclusion criteria

Patients with a history of diabetes or
Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) was precluded from the study.
Anatomic abnormalities of the penis or genital region,
Erectile dysfunction,
Chronic prostatitis,
Psychological disorder
Patients on anti-psychotic drugs.