Premature EjaculationPhase 3PENCT04085354
Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation
A Phase 3 study testing Multi-Vitamin Tablets, Dapoxetine and Dapoxetine and folic acid. in people with Premature Ejaculation, run by Sohag University at 1 site in Egypt.
Trial summary
This study will aim to assess of the clinical efficacy and safety of dapoxetine, combined dapoxetine with folic acid and combined dapoxetine with vitamin B12 in treatment of patients with premature ejaculation: A randomized placebo-controlled clinical trial. 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?
- Multi-Vitamin Tablets, Dapoxetine and Dapoxetine and folic acid.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2019to 29 Aug 2019
- 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
- Premature ejaculation
Who cannot join
- Erectile dysfunction
- Diabetes mellitus
- chronic prostatitis
- Advanced renal or hepatic diseases
- Neurological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation: A Randomized Placebo-controlled Clinical Trial
This study will aim to assess of the clinical efficacy and safety of dapoxetine, combined dapoxetine with folic acid and combined dapoxetine with vitamin B12 in treatment of patients with premature ejaculation: A randomized placebo-controlled clinical trial.
Read the detailed description
In a single-blind placebo-controlled clinical study, it will be carried out on 120 patients with PE.
All patients will be randomized equally divided into four groups (30 patients each).
Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
- Conditions
- Premature Ejaculation
- Being tested
- Multi-Vitamin Tablets, Dapoxetine, Dapoxetine and folic acid., Dapoxetine and vitamin B12
- 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.
Multi-Vitamin TabletsDrug
The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
DapoxetineDrug
The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.
Dapoxetine and folic acid.Drug
The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
Dapoxetine and vitamin B12Drug
The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. Receives: Drug: Multi-Vitamin Tablets |
| Dapoxetine | Active comparator | Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. Receives: Drug: Dapoxetine |
| Dapoxetine and folic acid. | Active comparator | Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid. Receives: Drug: Dapoxetine and folic acid. |
| Dapoxetine and vitamin B12 | Active comparator | Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12 Receives: Drug: Dapoxetine and vitamin B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arabic Index of Premature Ejaculation
The AIPE questionnaire includes seven questions.Response to each question will be scored on a scale from 1 to 5.
Measured: 0-6 weeks after treatment
Intravaginal ejaculatory latency times
By using stopwatches
Measured: 0-6 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 posted11 Sep 2019
- Study start10 Feb 2019
- Primary completion1 Jun 2019
- Study completion29 Aug 2019
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will be randomized equally divided into four groups (30 patients each).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 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
- Investigators
- Mohammed Abu El-Hamd, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085354
- Sponsor's protocol ID
- 2/2019
- Acronym
- PE
- Status last verified
- Aug 2019
- First submitted
- 30 Aug 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation: A Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04085354
- Acronym / sponsor ID
- PE / 2/2019
- Conditions
- Premature Ejaculation
- Keywords
- Premature Ejaculation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 11 Sep 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 will aim to assess of the clinical efficacy and safety of dapoxetine, combined dapoxetine with folic acid and combined dapoxetine with vitamin B12 in treatment of patients with premature ejaculation: A randomized placebo-controlled clinical trial.
Detailed description
In a single-blind placebo-controlled clinical study, it will be carried out on 120 patients with PE.
All patients will be randomized equally divided into four groups (30 patients each).
Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- All patients will be randomized equally divided into four groups (30 patients each).
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Multi-Vitamin TabletsGroup 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. |
| Dapoxetine | Active comparator | Drug: DapoxetineGroup 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. |
| Dapoxetine and folic acid. | Active comparator | Drug: Dapoxetine and folic acid.Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid. |
| Dapoxetine and vitamin B12 | Active comparator | Drug: Dapoxetine and vitamin B12Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Premature ejaculation
Key exclusion criteria (5 listed)
- Erectile dysfunction
- Diabetes mellitus
- chronic prostatitis
- Advanced renal or hepatic diseases
- 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 |
|---|---|---|
| Multi-Vitamin TabletsThe distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. | Drug | Placebo |
| DapoxetineThe distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. | Drug | Dapoxetine |
| Dapoxetine and folic acid.The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid. | Drug | Dapoxetine and folic acid. |
| Dapoxetine and vitamin B12The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12 | Drug | Dapoxetine and vitamin B12 |
Primary outcome
Arabic Index of Premature Ejaculation
Time frame: 0-6 weeks after treatment
The AIPE questionnaire includes seven questions.Response to each question will be scored on a scale from 1 to 5.
Intravaginal ejaculatory latency times
Time frame: 0-6 weeks after treatment
By 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 11 Sep 2019.
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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 Abu El-Hamd, MD principal investigator
Assistant Professor
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 Multi-Vitamin Tablets, Dapoxetine and Dapoxetine and folic acid. 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: finished, as of the sponsor's last update on 11 Sep 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 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?
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 (time frame: 0-6 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 11 Sep 2019.