Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature EjaculationPENCT04355949
Assessment of Serum Levels of Vitamin D, Vitamin B12 and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
A study testing Serum vitamin D, vitamin B12, folic acid in people with Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation, run by Sohag University at 1 site in Egypt.
Trial summary
Therefore, this study will aim to assess serum levels of vitamin D, vitamin B12 and folic acid among patients with lifelong PE and non-responding to dapoxetine treatment. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation
- What is being tested?
- Serum vitamin D, vitamin B12, folic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2020to 30 Jun 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- premature ejaculation
- non-responding to dapoxetine treatment.
Who cannot join
- diabetes mellitus,
- chronic prostatitis,
- Advanced renal or hepatic diseases
- neurological diseases and
- C.N.S. medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D, Vitamin B12, and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Therefore, this study will aim to assess serum levels of vitamin D, vitamin B12 and folic acid among patients with lifelong PE and non-responding to dapoxetine treatment.
Read the detailed description
We will consider the patients with LPE non-responding to dapoxetine treatment when they used the optimum dose (30 and 60mg) dapoxetine for 4 separate times with no response.
Serum vitamin D, vitamin B12, and folic acid levels will be assessed in all subjects included in the study. Venous blood samples will be drawn and kept into EDTA bottles in the morning between 8 and 10 a.m. after an overnight fast of about 10-14 hr.
- Being tested
- Serum vitamin D, vitamin B12, folic acid
- 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.
Serum vitamin D, vitamin B12, folic acidDiagnostic test
Also called Serum vitamin D, vitamin B12, folic acid levels
Serum vitamin D, vitamin B12, and folic acid levels will be assessed
| Study group | Role | What they receive |
|---|---|---|
| Patients with premature ejaculation | Experimental | Serum vitamin D, vitamin B12, and folic acid levels will be assessed Receives: Diagnostic Test: Serum vitamin D, vitamin B12, folic acid |
| Normal subjects | Experimental | Serum vitamin D, vitamin B12, and folic acid levels will be assessed Receives: Diagnostic Test: Serum vitamin D, vitamin B12, folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum vitamin D in patient with PE
Serum vitamin D levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Measured: 0-1 week
vitamin B12, in patient with PE
vitamin B12 levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Measured: 0-1 week
folic acid in patient with PE
folic acid levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Measured: 0-1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start28 Feb 2020
- Primary completion30 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D, Vitamin B12 and Folic Acid Among Patients With 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- assess serum levels of vitamin D, vitamin B12 and folic acid among patients with lifelong PE and non-responding to dapoxetine treatment.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 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, Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355949
- Sponsor's protocol ID
- 2/2020
- Acronym
- PE
- Status last verified
- Jan 2021
- First submitted
- 12 Apr 2020
- 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
- Vitamin D, Vitamin B12, and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
- ClinicalTrials.gov ID
- NCT04355949
- Acronym / sponsor ID
- PE / 2/2020
- Keywords
- Premature Ejaculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Apr 2020 (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 serum levels of vitamin D, vitamin B12 and folic acid among patients with lifelong PE and non-responding to dapoxetine treatment.
Detailed description
We will consider the patients with LPE non-responding to dapoxetine treatment when they used the optimum dose (30 and 60mg) dapoxetine for 4 separate times with no response.
Serum vitamin D, vitamin B12, and folic acid levels will be assessed in all subjects included in the study. Venous blood samples will be drawn and kept into EDTA bottles in the morning between 8 and 10 a.m. after an overnight fast of about 10-14 hr.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- assess serum levels of vitamin D, vitamin B12 and folic acid among patients with lifelong PE and non-responding to dapoxetine treatment.
| Arm | Type | Receives |
|---|---|---|
| Patients with premature ejaculation | Experimental | Diagnostic Test: Serum vitamin D, vitamin B12, folic acidSerum vitamin D, vitamin B12, and folic acid levels will be assessed |
| Normal subjects | Experimental | Diagnostic Test: Serum vitamin D, vitamin B12, folic acidSerum vitamin D, vitamin B12, and folic acid levels will be assessed |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- premature ejaculation
- non-responding to dapoxetine treatment.
Key exclusion criteria (5 listed)
- diabetes mellitus,
- chronic prostatitis,
- Advanced renal or hepatic diseases
- neurological diseases and
- 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 |
|---|---|---|
| Serum vitamin D, vitamin B12, folic acidAlso: Serum vitamin D, vitamin B12, folic acid levelsSerum vitamin D, vitamin B12, and folic acid levels will be assessed | Diagnostic test | Normal subjects, Patients with premature ejaculation |
Primary outcome
Serum vitamin D in patient with PE
Time frame: 0-1 week
Serum vitamin D levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
vitamin B12, in patient with PE
Time frame: 0-1 week
vitamin B12 levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
folic acid in patient with PE
Time frame: 0-1 week
folic acid levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
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 Jan 2021.
- Individual participant dataSharing planned: No
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
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 study testing Serum vitamin D, vitamin B12, folic acid in people with Vitamin D, Vitamin B12 and Folic Acid Among Patients 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 2 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 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.
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?
Serum vitamin D in patient with PE (time frame: 0-1 week). The study lists 3 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.