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.

NCT ID: NCT04703127

Last Updated: 2021-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2021-01-30

Brief Summary

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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

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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.

Conditions

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Premature Ejaculation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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 Groups

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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.

Group Type ACTIVE_COMPARATOR

Tadalafil and Combined Dapoxietine

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Dapoxietine and Combined Lidocaine 5% Spray

Intervention Type DRUG

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.

Interventions

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Tadalafil and Combined Dapoxietine

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Tadalafil with Combined Dapoxietine Dapoxietine With Lidocaine 5% Spray

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Abu El-Hamd

Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed A El-Hamd

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Mohammed Abu El-Hamd

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammed A Abu El-Hamd, MD

Role: CONTACT

01004139060

Mohammed Abu El-Hamd, MD

Role: CONTACT

01004139060

Facility Contacts

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Mohammed A Abu El-Hamd, MD

Role: primary

01004139060

Other Identifiers

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3/2020

Identifier Type: -

Identifier Source: org_study_id

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