Lidocaine SprayPhase 2PENCT04062357
Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients.
A Phase 2 study testing Lidocaine 5% spray in people with Lidocaine Spray, run by Sohag University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Lidocaine Spray
- What is being tested?
- Lidocaine 5% spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2018to 20 Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of lifelong premature ejaculation
Who cannot join
- renal or liver diseases,
- diabetes mellitus,
- thyroid diseases,
- chronic prostatitis,
- neurological diseases
- allergic reactions to local anesthetics or alcohols.
- erectil dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients. A Randomized Single-blind Placebo-controlled Clinical Trial.
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.
Read the 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.
- Conditions
- Lidocaine Spray
- Being tested
- Lidocaine 5% spray, Placebo
- Keywords
- Premature Ejaculation
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 5% sprayDrug
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).
PlaceboOther
Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arabic Index of Premature Ejaculation Scores
Patients were informed to fulfill the questionnaires of Arabic Index of Premature Ejaculation (AIPE).
Measured: 0-8 weeks after treatment
Intravaginal ejaculatory latency times
Patients were informed to sign up intravaginal ejaculatory latency times (IELTs) using stopwatches.
Measured: 0-8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start20 Apr 2018
- Primary completion20 Jan 2019
- Study completion20 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lidocaine SprayStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abu El-Hamd, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062357
- Sponsor's protocol ID
- 3/2019
- Acronym
- PE
- Status last verified
- Oct 2019
- First submitted
- 14 Aug 2019
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients. A Randomized Single-blind Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04062357
- Acronym / sponsor ID
- PE / 3/2019
- Conditions
- Lidocaine Spray
- Keywords
- Premature Ejaculation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 20 Apr 2019 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| lidocaine 5% spray | Active comparator | Drug: Lidocaine 5% sprayGroup 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 | Placebo comparator | Other: PlaceboGroup 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). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of lifelong premature ejaculation
Key exclusion criteria (7 listed)
- renal or liver diseases,
- diabetes mellitus,
- thyroid diseases,
- chronic prostatitis,
- neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 5% sprayGroup 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 |
| PlaceboGroup 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks. | Other | Placebo |
Primary outcome
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).
Intravaginal ejaculatory latency times
Time frame: 0-8 weeks after treatment
Patients were informed to sign up intravaginal ejaculatory latency times (IELTs) using stopwatches.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine 5% spray in people with Lidocaine Spray, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arabic Index of Premature Ejaculation Scores (time frame: 0-8 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.