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

NCT04062357 | Completed Phase 2 DMC

• 1 other identifier: 3/2019
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Lidocaine Spray

Keywords

Premature Ejaculation

Outcome Measures

Primary Outcomes (2)

• 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

• Intravaginal ejaculatory latency times

  Patients were informed to sign up intravaginal ejaculatory latency times (IELTs) using stopwatches.

  0-8 weeks after treatment

Study Arms (2)

lidocaine 5% spray

ACTIVE COMPARATOR

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).

Drug: Lidocaine 5% spray

Placebo

PLACEBO COMPARATOR

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).

Other: Placebo

Interventions

Lidocaine 5% spray DRUG

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).

lidocaine 5% spray

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of lifelong premature ejaculation

You may not qualify if:

• renal or liver diseases,
• diabetes mellitus,
• thyroid diseases,
• chronic prostatitis,
• neurological diseases
• allergic reactions to local anesthetics or alcohols.
• erectil dysfunction

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine, Sohag University, Egypt

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients were randomized evenly categorized into two treatment groups. Patient's distribution in the two groups was according to randomized encoded ballots, and they were unobservant of the type of the topical medications used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt.

Model Details: 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). 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).

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 20, 2019
• Study Start: April 20, 2018
• Primary Completion: January 20, 2019
• Study Completion: April 20, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)