Effectiveness and Tolerability of the On-demand Use of Combined Dapoxetine With Tadalafil and Combined Dapoxetine With Lidocaine 5% Spray in Treatment of Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.

Phase 3

• Conditions: Premature Ejaculation
• Interventions: Drug: Dapoxietine and Combined Lidocaine 5% Spray; Drug: Tadalafil and Combined Dapoxietine

• Registration Number: NCT04703127
• Lead Sponsor: Sohag University

Brief Summary

Therefore, this study will aim to assess the effectiveness and tolerability of the on-demand use of combined dapoxetine with tadalafil and combined dapoxetine with lidocaine 5% spray in treatment of patients with lifelong premature ejaculation and non-responding to dapoxetine alone.

Detailed Description

This study will be carried out on 60 patients with lifelong premature ejaculation and non-responding to dapoxetine alone.

All patients will be equally divided into 2 groups (30 patients each). Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.

Study Timeline

• Study Start: 2020-03-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-08
• Last Update Submitted: 2021-01-08
• Study First Posted: 2021-01-11
• Last Update Posted: 2021-01-11
• Primary Completion: 2021-01-30
• Study Completion: 2021-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• lifelong premature ejaculation and non-responding to dapoxetine alone.

Exclusion Criteria

• diabetes mellitus,
• chronic prostatitis,
• Advanced renal or hepatic diseases
• neurological diseases
• C.N.S. medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.	Dapoxietine and Combined Lidocaine 5% Spray	Group 2 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.
Patients with lifelong premature ejaculation and non-responding to dapoxetine alone	Tadalafil and Combined Dapoxietine	Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse.

Primary Outcome Measures

Name	Time	Method
Intravaginal ejaculatory latency time (IELT)	0-8 weeks
Arabic Index of Premature Ejaculation (AIPE)	0-8 week

Trial Locations

Locations (1)

Mohammed Abu El-Hamd; 🇪🇬 Sohag, Egypt