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NCT Number: NCT04062357

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

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.

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Key information

Conditions

Lidocaine Spray Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Premature Ejaculation Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Sohag University, Egypt

Sohag, 82524, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of lifelong premature ejaculation

Exclusion criteria

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

Treatment and study plan

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).

Placebo

Other

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

Primary outcomes

  1. Arabic Index of Premature Ejaculation Scores

    Time frame: 0-8 weeks after treatment

    Patients were informed to fulfill the questionnaires of Arabic Index of Premature Ejaculation (AIPE).

  2. Intravaginal ejaculatory latency times

    Time frame: 0-8 weeks after treatment

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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Acronym: PE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 20, 2019
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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