Lidocaine Spray Clinical Trial
— PEOfficial title:
Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients. A Randomized Single-blind Placebo-controlled Clinical Trial.
Verified date | October 2019 |
Source | Sohag University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine, Sohag University, Egypt | Sohag |
Lead Sponsor | Collaborator |
---|---|
Sohag University |
Egypt,
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 |