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.

Premature Ejaculation Clinical Trial

— PE  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04703127
• Other study ID #: 3/2020
• Status: Recruiting
• Phase: Phase 3
• Start date: March 30, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: January 2021
• Source: Sohag University
• Contact: Mohammed A Abu El-Hamd, MD
• Phone: 01004139060
• Email: Mohammedadva[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• Tadalafil and Combined Dapoxietine
Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse.
• 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.

Locations

Country	Name	City	State
Egypt	Mohammed Abu El-Hamd	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravaginal ejaculatory latency time (IELT)		0-8 weeks
Primary	Arabic Index of Premature Ejaculation (AIPE)		0-8 week