Premature EjaculationPhase 3PENCT04703127
Effectiveness and Tolerability of the On-demand Use of Combined Dapoxetine With Tadalafil and Combined Dapoxetine With Lidocaine 5% Spray in Treatment of Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.
A Phase 3 study testing Tadalafil and Combined Dapoxietine and Dapoxietine and Combined Lidocaine 5% Spray in people with Premature Ejaculation, run by Sohag University at 1 site in Egypt.
Trial summary
Therefore, this study will aim to assess the effectiveness and tolerability of the on-demand use of combined dapoxetine with tadalafil and combined dapoxetine with lidocaine 5% spray in treatment of patients with lifelong premature ejaculation and non-responding to dapoxetine alone. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Tadalafil and Combined Dapoxietine and Dapoxietine and Combined Lidocaine 5% Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2020to 30 Jan 2021
- Phase
- Phase 3
- 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
- lifelong premature ejaculation and non-responding to dapoxetine alone.
Who cannot join
- diabetes mellitus,
- chronic prostatitis,
- Advanced renal or hepatic diseases
- neurological diseases
- C.N.S. medications
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mohammed Abu El-Hamd
Sohag, 82524
Mohammed A Abu El-Hamd, MD, 01004139060, Mohammedadva@yahoo.com
About this study
Therefore, this study will aim to assess the effectiveness and tolerability of the on-demand use of combined dapoxetine with tadalafil and combined dapoxetine with lidocaine 5% spray in treatment of patients with lifelong premature ejaculation and non-responding to dapoxetine alone.
Read the detailed description
This study will be carried out on 60 patients with lifelong premature ejaculation and non-responding to dapoxetine alone.
All patients will be equally divided into 2 groups (30 patients each). Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.
- Conditions
- Premature Ejaculation
- Being tested
- Tadalafil and Combined Dapoxietine, Dapoxietine and Combined Lidocaine 5% Spray
- 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.
Tadalafil and Combined DapoxietineDrug
Also called Tadalafil with Combined Dapoxietine
Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse.
Dapoxietine and Combined Lidocaine 5% SprayDrug
Also called Dapoxietine With Lidocaine 5% Spray
Group 2 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lifelong premature ejaculation and non-responding to dapoxetine alone | Active comparator | Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Receives: Drug: Tadalafil and Combined Dapoxietine |
| Patients with Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone. | Active comparator | Group 2 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse. Receives: Drug: Dapoxietine and Combined Lidocaine 5% Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravaginal ejaculatory latency time (IELT)
Measured: 0-8 weeks
Arabic Index of Premature Ejaculation (AIPE)
Measured: 0-8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start30 Mar 2020
- Primary completion30 Jan 2021 (estimated)
- Study completion30 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All patients will be equally divided into 2 groups (30 patients each). Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abu El-Hamd, Sohag University
- Investigators
- Mohammed A El-Hamd, Principal investigator, Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703127
- Sponsor's protocol ID
- 3/2020
- Acronym
- PE
- Status last verified
- Jan 2021
- First submitted
- 7 Jan 2021
- Last updated
- 11 Jan 2021
- 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 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerability of the On-demand Use of Combined Dapoxetine With Tadalafil and Combined Dapoxetine With Lidocaine 5% Spray in Treatment of Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.
- ClinicalTrials.gov ID
- NCT04703127
- Acronym / sponsor ID
- PE / 3/2020
- Conditions
- Premature Ejaculation
- Keywords
- Premature Ejaculation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 11 Jan 2021 (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.
Therefore, this study will aim to assess the effectiveness and tolerability of the on-demand use of combined dapoxetine with tadalafil and combined dapoxetine with lidocaine 5% spray in treatment of patients with lifelong premature ejaculation and non-responding to dapoxetine alone.
Detailed description
This study will be carried out on 60 patients with lifelong premature ejaculation and non-responding to dapoxetine alone.
All patients will be equally divided into 2 groups (30 patients each). Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- All patients will be equally divided into 2 groups (30 patients each). Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.
| Arm | Type | Receives |
|---|---|---|
| Patients with lifelong premature ejaculation and non-responding to dapoxetine alone | Active comparator | Drug: Tadalafil and Combined DapoxietineGroup 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. |
| Patients with Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone. | Active comparator | Drug: Dapoxietine and Combined Lidocaine 5% SprayGroup 2 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- lifelong premature ejaculation and non-responding to dapoxetine alone.
Key exclusion criteria (5 listed)
- diabetes mellitus,
- chronic prostatitis,
- Advanced renal or hepatic diseases
- neurological diseases
- C.N.S. medications
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 |
|---|---|---|
| Tadalafil and Combined DapoxietineAlso: Tadalafil with Combined DapoxietineGroup 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. | Drug | Patients with lifelong premature ejaculation and non-responding to dapoxetine alone |
| Dapoxietine and Combined Lidocaine 5% SprayAlso: Dapoxietine With Lidocaine 5% SprayGroup 2 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse. | Drug | Patients with Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone. |
Primary outcome
Intravaginal ejaculatory latency time (IELT)
Time frame: 0-8 weeks
Arabic Index of Premature Ejaculation (AIPE)
Time frame: 0-8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- 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.
Mohammed A El-Hamd principal investigator
Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tadalafil and Combined Dapoxietine and Dapoxietine and Combined Lidocaine 5% Spray in people with Premature Ejaculation, 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 5 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: status not confirmed, as of the sponsor's last update on 11 Jan 2021. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A Abu El-Hamd, MD (01004139060, Mohammedadva@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravaginal ejaculatory latency time (IELT) (time frame: 0-8 weeks). 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 11 Jan 2021.