NCT04703127

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

January 7, 2021

Last Update Submit

January 8, 2021

Conditions

Premature Ejaculation

Keywords

Premature Ejaculation

Outcome Measures

Primary Outcomes (2)

  • Intravaginal ejaculatory latency time (IELT)

    0-8 weeks

  • Arabic Index of Premature Ejaculation (AIPE)

    0-8 week

Study Arms (2)

Patients with lifelong premature ejaculation and non-responding to dapoxetine alone

ACTIVE COMPARATOR

Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse.

Drug: Tadalafil and Combined Dapoxietine

Patients with Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.

ACTIVE COMPARATOR

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

Interventions

Tadalafil and Combined DapoxietineDRUG

Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse.

Also known as: Tadalafil with Combined Dapoxietine
Patients with lifelong premature ejaculation and non-responding to dapoxetine alone
Dapoxietine and Combined Lidocaine 5% SprayDRUG

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.

Also known as: Dapoxietine With Lidocaine 5% Spray
Patients with Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.

Eligibility Criteria

Age20 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale Patients with PE
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed Abu El-Hamd

Sohag, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

Premature Ejaculation

Interventions

TadalafilLidocaine

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mohammed A El-Hamd

    Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed A Abu El-Hamd, MD

CONTACT

01004139060Mohammedadva@yahoo.com

Mohammed Abu El-Hamd, MD

CONTACT

01004139060Mohammedadva@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt.

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

March 30, 2020

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)