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

Lidocaine Spray Clinical Trial

— PE  

Official title:

Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients. A Randomized Single-blind Placebo-controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062357
• Other study ID #: 3/2019
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2018
• Est. completion date: April 20, 2019

Study information

• Verified date: October 2019
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. All medications were applied on the glans penis for 10-20 minutes and then cleaned before planed sexual intercourse. Patients were evaluated with Arabic Index of Premature Ejaculation (AIPE) scores, intravaginal ejaculatory latency times (IELTs), and frequency of sexual intercourse before and after treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 20, 2019
• Est. primary completion date: January 20, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

Clinical diagnosis of lifelong premature ejaculation

Exclusion Criteria:

1. renal or liver diseases,

2. diabetes mellitus,

3. thyroid diseases,

4. chronic prostatitis,

5. neurological diseases

6. allergic reactions to local anesthetics or alcohols.

7. erectil dysfunction

Related Conditions & MeSH terms

• Lidocaine Spray
• Premature Birth
• Premature Ejaculation

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Sohag University, Egypt	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arabic Index of Premature Ejaculation Scores	Patients were informed to fulfill the questionnaires of Arabic Index of Premature Ejaculation (AIPE).	0-8 weeks after treatment
Primary	Intravaginal ejaculatory latency times	Patients were informed to sign up intravaginal ejaculatory latency times (IELTs) using stopwatches.	0-8 weeks after treatment