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)

Sohag University

Status and phase: Unknown; Phase 3

Conditions: Premature Ejaculation

Treatments: Drug: Dapoxietine and Combined Lidocaine 5% Spray; Drug: Tadalafil and Combined Dapoxietine

Study type: Interventional

Funder types: Other

Identifiers

NCT04703127

3/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

Drug: Tadalafil and Combined Dapoxietine

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

Active Comparator group

Description:

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.

Treatment:

Drug: Dapoxietine and Combined Lidocaine 5% Spray