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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.

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.

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04703127
Acronym
PE
Enrollment
60
Registered
2021-01-11
Start date
2020-03-30
Completion date
2021-01-30
Last updated
2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ejaculation

Keywords

Premature Ejaculation

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.

Interventions

DRUGTadalafil and Combined Dapoxietine

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

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.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.

Intervention 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.

Eligibility

Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Intravaginal ejaculatory latency time (IELT)0-8 weeks
Arabic Index of Premature Ejaculation (AIPE)0-8 week

Countries

Egypt

Contacts

Primary ContactMohammed A Abu El-Hamd, MD
Mohammedadva@yahoo.com01004139060
Backup ContactMohammed Abu El-Hamd, MD
Mohammedadva@yahoo.com01004139060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026