Back to resultsEffectiveness 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. (PE)
Primary Purpose
Premature Ejaculation
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Tadalafil and Combined Dapoxietine
Dapoxietine and Combined Lidocaine 5% Spray
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ejaculation focused on measuring Premature Ejaculation
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
Sites / Locations
- Mohammed Abu El-HamdRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients with lifelong premature ejaculation and non-responding to dapoxetine alone
Patients with Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.
Arm Description
Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse.
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.
Outcomes
Primary Outcome Measures
Intravaginal ejaculatory latency time (IELT)
Arabic Index of Premature Ejaculation (AIPE)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04703127
Brief 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.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Anticipated)
Study Completion Date
January 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
Premature Ejaculation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
Investigator
Masking 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.
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with lifelong premature ejaculation and non-responding to dapoxetine alone
Arm Type
Active Comparator
Arm Description
Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse.
Arm Title
Patients with Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tadalafil and Combined Dapoxietine
Other Intervention Name(s)
Tadalafil with Combined Dapoxietine
Intervention Description
Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse.
Intervention Type
Drug
Intervention Name(s)
Dapoxietine and Combined Lidocaine 5% Spray
Other Intervention Name(s)
Dapoxietine With Lidocaine 5% Spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intravaginal ejaculatory latency time (IELT)
Time Frame
0-8 weeks
Title
Arabic Index of Premature Ejaculation (AIPE)
Time Frame
0-8 week
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male Patients with PE
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed A Abu El-Hamd, MD
Phone
01004139060
Email
Mohammedadva@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Abu El-Hamd, MD
Phone
01004139060
Email
Mohammedadva@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A El-Hamd
Organizational Affiliation
Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohammed Abu El-Hamd
City
Sohag
ZIP/Postal Code
82524
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed A Abu El-Hamd, MD
Phone
01004139060
Email
Mohammedadva@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
We'll reach out to this number within 24 hrs