Premature EjaculationVITAMIN B12NCT07036497
THE IMPACT OF VITAMIN B12 TREATMENT ON EJACULATORY FUNCTIONS IN MEN: SYMPTOMATIC RELIEF AND IMPROVED OUTCOMES
An observational study of Premature Ejaculation, run by OZGUR EKICI at 1 site in Turkey (Türkiye).
Trial summary
Aim: To investigate whether intramuscular B12 treatment has an effect on ejaculation in male patients with B12 deficiency. Methods: Male patients who were diagnosed with vitamin B12 deficiency in the internal medicine outpatient clinic between October 2024 and March 2025 and started intramuscular B12 treatment were… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Vitamin B12
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 May 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male patients aged 18-70 years who were admitted to the internal medicine outpatient clinic of Bursa City Hospital between October 2024 and March 2025 with non-specific gastrointestinal complaints or to investigate the etiology of anemia and who were started on intramuscular vitamin B12 due to vitamin B12 deficiency were included in the study
Male patients aged 18-70 years who were admitted to the internal medicine outpatient clinic between October 2024 and March 2025 with non-specific gastrointestinal complaints or to investigate the etiology of anemia and who were started on intramuscular vitamin B12 due to vitamin B12 deficiency were included in the study
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Trial locations and contacts
1 site in 1 country.
About this study
Aim: To investigate whether intramuscular B12 treatment has an effect on ejaculation in male patients with B12 deficiency.
Methods: Male patients who were diagnosed with vitamin B12 deficiency in the internal medicine outpatient clinic between October 2024 and March 2025 and started intramuscular B12 treatment were included in the study. The scores obtained from the self-estimated intravaginal ejaculation latency time (IELT), premature ejaculation diagnostic tool (PEDT) and premature ejaculation profile (PEP) questionnaires reflecting the ejaculatory status of these patients before treatment were recorded. After 3 months of treatment, these scores were re-recorded by phone call.
Read more
The scores recorded before and after treatment were compared. Results: The study included 54 patients. The mean age of the patients was 43.46±13.3 years, mean pretreatment IELT was 2.4±1.4 min, and mean pre-treatment PEDT score was 11.3±4.8. In both the whole patient group and the premature ejaculation (PE) group, a statistically significant difference was observed in the items of perceived control over ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation from the PEP questionnaire form after treatment, no significant change was found in the item of personal distress related to ejaculation.
PEDT scores showed statistically significant improvement after treatment both in the whole patient group and in the PE group. In terms of IELT, no differences was observed in the whole patient group after treatment, whereas statistically significant improvement was observed in the PE group.
Conclusion: Intramuscular vitamin B12 may improve ejaculation times and satisfaction levels in patient's questionnaires forms in male patients.
- Conditions
- Premature Ejaculation
- Being tested
- Vitamin B12
- Keywords
- premature ejaculation, intravaginal ejaculatory latancy time, premature ejaculation diagnostic tool, vitamin B12, premature ejaculation profile
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12Drug
Vitamin B12 treatment was initiated in male patients with vitamin B12 deficiency due to anemia etiology.
What is being measured
The primary outcome is the main question the study is designed to answer.
intravaginal ejaculation latency time after treatment
intravaginal ejaculation latency time after treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Oct 2024
- Primary completion1 Mar 2025
- Study completion1 May 2025
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- OZGUR EKICI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, OZGUR EKICI, Erzincan Binali Yildirim Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036497
- Sponsor's protocol ID
- 2024-15/6
- Acronym
- VITAMIN B12
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE IMPACT OF VITAMIN B12 TREATMENT ON EJACULATORY FUNCTIONS IN MEN: SYMPTOMATIC RELIEF AND IMPROVED OUTCOMES
- ClinicalTrials.gov ID
- NCT07036497
- Acronym / sponsor ID
- VITAMIN B12 / 2024-15/6
- Conditions
- Premature Ejaculation
- Keywords
- premature ejaculation, intravaginal ejaculatory latancy time, premature ejaculation diagnostic tool, vitamin B12, premature ejaculation profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- OZGUR EKICIUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 25 Jun 2025 (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.
Aim: To investigate whether intramuscular B12 treatment has an effect on ejaculation in male patients with B12 deficiency.
Methods: Male patients who were diagnosed with vitamin B12 deficiency in the internal medicine outpatient clinic between October 2024 and March 2025 and started intramuscular B12 treatment were included in the study. The scores obtained from the self-estimated intravaginal ejaculation latency time (IELT), premature ejaculation diagnostic tool (PEDT) and premature ejaculation profile (PEP) questionnaires reflecting the ejaculatory status of these patients before treatment were recorded. After 3 months of treatment, these scores were re-recorded by phone call.
The scores recorded before and after treatment were compared. Results: The study included 54 patients. The mean age of the patients was 43.46±13.3 years, mean pretreatment IELT was 2.4±1.4 min, and mean pre-treatment PEDT score was 11.3±4.8. In both the whole patient group and the premature ejaculation (PE) group, a statistically significant difference was observed in the items of perceived control over ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation from the PEP questionnaire form after treatment, no significant change was found in the item of personal distress related to ejaculation.
PEDT scores showed statistically significant improvement after treatment both in the whole patient group and in the PE group. In terms of IELT, no differences was observed in the whole patient group after treatment, whereas statistically significant improvement was observed in the PE group.
Conclusion: Intramuscular vitamin B12 may improve ejaculation times and satisfaction levels in patient's questionnaires forms in male patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male patients aged 18-70 years who were admitted to the internal medicine outpatient clinic of Bursa City Hospital between October 2024 and March 2025 with non-specific gastrointestinal complaints or to investigate the etiology of anemia and who were started on intramuscular vitamin B12 due to vitamin B12 deficiency were included in the study
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 |
|---|---|---|
| Vitamin B12Vitamin B12 treatment was initiated in male patients with vitamin B12 deficiency due to anemia etiology. | Drug | – |
Primary outcome
intravaginal ejaculation latency time after treatment
Time frame: 6 months
intravaginal ejaculation latency time after 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 25 Jun 2025.
- 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?
An observational study of Premature Ejaculation, run by OZGUR EKICI at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Jun 2025. 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 Turkey (Türkiye). 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?
intravaginal ejaculation latency time after treatment (time frame: 6 months). 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 25 Jun 2025.