Evaluation 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

Phase 3

Completed

• Conditions: Premature Ejaculation
• Interventions: Drug: Dapoxetine and vitamin B12; Drug: Dapoxetine and folic acid.; Drug: Multi-Vitamin Tablets; Drug: Dapoxetine

• Registration Number: NCT04085354
• Lead Sponsor: Sohag University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2019-02-10
• Primary Completion: 2019-06-01
• Status Verified: 2019-08
• Study Completion: 2019-08-29
• Study First Submitted: 2019-08-30
• Study First Submitted QC: 2019-09-07
• Last Update Submitted: 2019-09-07
• Study First Posted: 2019-09-11
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

Premature ejaculation

Exclusion Criteria

• Erectile dysfunction
• Diabetes mellitus
• chronic prostatitis
• Advanced renal or hepatic diseases
• Neurological diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapoxetine and vitamin B12	Dapoxetine and vitamin B12	Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
Dapoxetine and folic acid.	Dapoxetine and folic acid.	Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
Placebo	Multi-Vitamin Tablets	Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
Dapoxetine	Dapoxetine	Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.

Primary Outcome Measures

Name	Time	Method
Arabic Index of Premature Ejaculation	0-6 weeks after treatment	The AIPE questionnaire includes seven questions.Response to each question will be scored on a scale from 1 to 5.
Intravaginal ejaculatory latency times	0-6 weeks after treatment	By using stopwatches

Trial Locations

Locations (1)

Faculty of Medicine, Sohag University, Egypt; 🇪🇬 Sohag, Egypt