Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation

Beni-Suef University

Status and phase: Completed; Phase 4

Conditions: Premature (Early) Ejaculation

Treatments: Drug: Oral intake of medication

Study type: Interventional

Funder types: Other

Identifiers

NCT07113145

FMBSUREC/07052024/Ahmed

Details and patient eligibility

About

This randomized controlled trial evaluated the comparative effectiveness and safety of four pharmacological treatments-Citalopram 20mg, Silodosin 4 mg, Dapoxetine 30 mg on demand, and Dapoxetine 30 mg daily-in men with premature ejaculation (PE). A total of 400 male patients were enrolled at Beni-Suef University Hospital and randomly assigned to one of four treatment groups (n=100). The primary outcome was the change in intravaginal ejaculatory latency time (IVELT), while secondary outcomes included ejaculatory control and sexual satisfaction, assessed using the Premature Ejaculation Profile Questionnaire (PEPQ). Side effects were also evaluated using multivariate regression analysis.

Enrollment: 450 patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of PE according to Premature Ejaculation Profile Questionnaire (PEPQ) and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR)[12].

• Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline)

• Inability to delay ejaculation during all or nearly all vaginal penetrations

• Negative personal consequences (distress, frustration, avoidance of sexual intimacy)

• PEPQ score ≥11.

  • Age ≥ 20 years.
  • In a stable, monogamous, heterosexual relationship for at least 3 months.
  • Signed informed consent indicating willingness to participate.

Exclusion criteria

• Use of PE medications in the preceding 4 weeks.
• Use of hormonal supplements.
• Patients with erectile dysfunction diagnosed by International Index of Erectile Function.
• History of psychiatric or significant physical disorders (in either patient or partner).
• Use of antidepressants, local anesthetic sprays, intracavernosal injections, or psychotherapy within 4 weeks.
• Alcohol or substance abuse.
• Documented hypotension.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 4 patient groups

Received Citalopram, starting with 10 mg once daily for 1 week, followed by 20 for 10 weeks

Active Comparator group

Treatment:

Drug: Oral intake of medication

Drug: Oral intake of medication

Drug: Oral intake of medication

Drug: Oral intake of medication

Received Silodosin 4mg, administered orally once daily.

Active Comparator group

Treatment:

Drug: Oral intake of medication

Drug: Oral intake of medication

Drug: Oral intake of medication

Drug: Oral intake of medication

Received Dapoxetine 30 mg, taken 2 hours before intercourse, on-demand, min 8/ month for 3 mon

Active Comparator group

Treatment:

Drug: Oral intake of medication

Drug: Oral intake of medication

Drug: Oral intake of medication

Drug: Oral intake of medication

Received Dapoxetine hydrochloride 30 mg, administered daily.

Active Comparator group

Treatment:

Drug: Oral intake of medication

Drug: Oral intake of medication

Drug: Oral intake of medication

Drug: Oral intake of medication