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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04062357
Other study ID # 3/2019
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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