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.

Study Overview
=================
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.

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.

Conditions
-----------------
Premature Ejaculation

Intervention / Treatment
-----------------
* Drug: Tadalafil and Combined Dapoxietine
* Drug: Dapoxietine and Combined Lidocaine 5% Spray


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with lifelong premature ejaculation and non-responding to dapoxetine alone<br>Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. | Drug: Tadalafil and Combined Dapoxietine<br>* Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse.<br>* Other names: Tadalafil with Combined Dapoxietine;|
| Active Comparator: Patients with Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.<br>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. | Drug: Dapoxietine and Combined Lidocaine 5% Spray<br>* 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.<br>* Other names: Dapoxietine With Lidocaine 5% Spray;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravaginal ejaculatory latency time (IELT) |  | 0-8 weeks | 
| Arabic Index of Premature Ejaculation (AIPE) |  | 0-8 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature Ejaculation