MedTrace Logo

Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients.

NCT04062357 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-10-07

No results posted yet for this study

Summary

This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.

Conditions

  • Lidocaine Spray

Interventions

DRUG

Lidocaine 5% spray

Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks (One to two applications (1-2 ml) of lidocaine 5% sprays; contain 5 -10 mg of lidocaine, in a metered dose aerosol-delivery system).

OTHER

Placebo

Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2019-01-20
Completion
2019-04-20

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04062357 on ClinicalTrials.gov