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. (PE)

January 8, 2021 updated by: Mohammed Abu El-Hamd, Sohag University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Recruiting
        • Mohammed Abu El-Hamd
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Mohammed A El-Hamd, Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2020

Primary Completion (Anticipated)

January 30, 2021

Study Completion (Anticipated)

January 30, 2021

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 8, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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