search
Back to results

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

Primary Purpose

Lidocaine Spray

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Lidocaine 5% spray
Placebo
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lidocaine Spray focused on measuring Premature Ejaculation

Eligibility Criteria

20 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine, Sohag University, Egypt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

lidocaine 5% spray

Placebo

Arm Description

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).

Outcomes

Primary Outcome Measures

Arabic Index of Premature Ejaculation Scores
Patients were informed to fulfill the questionnaires of Arabic Index of Premature Ejaculation (AIPE).
Intravaginal ejaculatory latency times
Patients were informed to sign up intravaginal ejaculatory latency times (IELTs) using stopwatches.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2019
Last Updated
October 3, 2019
Sponsor
Sohag University
search

1. Study Identification

Unique Protocol Identification Number
NCT04062357
Brief Title
Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
January 20, 2019 (Actual)
Study Completion Date
April 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lidocaine Spray
Keywords
Premature Ejaculation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lidocaine 5% spray
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Lidocaine 5% spray
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.
Primary Outcome Measure Information:
Title
Arabic Index of Premature Ejaculation Scores
Description
Patients were informed to fulfill the questionnaires of Arabic Index of Premature Ejaculation (AIPE).
Time Frame
0-8 weeks after treatment
Title
Intravaginal ejaculatory latency times
Description
Patients were informed to sign up intravaginal ejaculatory latency times (IELTs) using stopwatches.
Time Frame
0-8 weeks after treatment

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Medicine, Sohag University, Egypt
City
Sohag
ZIP/Postal Code
82524
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs