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Status unknownNCT04703127PEUpdated Jan 11, 2021

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.

A Phase 3 interventional study of Tadalafil and Combined Dapoxietine and Dapoxietine and Combined Lidocaine 5% Spray in Premature Ejaculation, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to male participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-01-11.

Sponsored by Sohag University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Mar 2020, registered Jan 2021).
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
20 Years to 50 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Premature Ejaculation

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Keywords

  • Premature Ejaculation
03

In context

Premature Ejaculation

106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.

This study's planned enrollment of 60 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.

Browse Premature Ejaculation studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • diabetes mellitus,
  • chronic prostatitis,
  • Advanced renal or hepatic diseases
  • neurological diseases
  • C.N.S. medications
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugTadalafil and Combined Dapoxietine

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

    Also known as: Tadalafil with Combined Dapoxietine

  • DrugDapoxietine 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.

    Also known as: Dapoxietine With Lidocaine 5% Spray

06

What researchers measure

Primary outcomes

  1. Intravaginal ejaculatory latency time (IELT)

    Time frame: 0-8 weeks

  2. Arabic Index of Premature Ejaculation (AIPE)

    Time frame: 0-8 week

07

Study locations

1 of 1 sites recruiting
  • Mohammed Abu El-Hamd
    Sohag, 82524, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2020 (actual). Primary completion is estimated for Jan 2021, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2021
First posted
Jan 11, 2021
StartActual
Mar 30, 2020
Primary completionEst.
Jan 30, 2021
CompletionEst.
Jan 30, 2021
Last update
Jan 11, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04703127
Lead sponsor
Sohag University
Responsible party
Mohammed Abu El-Hamd (Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt., Sohag University) — Principal investigator
First posted
Jan 11, 2021
Start date
Mar 30, 2020
Primary completion
Jan 30, 2021 (estimated)
Completion
Jan 30, 2021 (estimated)
Last update
Jan 11, 2021

Study contacts

Mohammed A Abu El-Hamd, MD
Contact
Mohammedadva@yahoo.com
01004139060
Mohammed Abu El-Hamd, MD
Contact
Mohammedadva@yahoo.com
01004139060
Mohammed A El-Hamd
principal investigator · Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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