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

Phase 2

Completed

• Conditions: Lidocaine Spray
• Interventions: Other: Placebo; Drug: Lidocaine 5% spray

• Registration Number: NCT04062357
• Lead Sponsor: Sohag University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-04-20
• Primary Completion: 2019-01-20
• Study Completion: 2019-04-20
• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-18
• Study First Posted: 2019-08-20
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-03
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks (One to two applications (1-2 ml) of alcohol 70% sprays).
lidocaine 5% spray	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).

Primary Outcome Measures

Name	Time	Method
Arabic Index of Premature Ejaculation Scores	0-8 weeks after treatment	Patients were informed to fulfill the questionnaires of Arabic Index of Premature Ejaculation (AIPE).
Intravaginal ejaculatory latency times	0-8 weeks after treatment	Patients were informed to sign up intravaginal ejaculatory latency times (IELTs) using stopwatches.

Trial Locations

Locations (1)

Faculty of Medicine, Sohag University, Egypt; 🇪🇬 Sohag, Egypt