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CompletedNCT07036497VITAMIN B12Updated Jun 25, 2025

THE IMPACT OF VITAMIN B12 TREATMENT ON EJACULATORY FUNCTIONS IN MEN: SYMPTOMATIC RELIEF AND IMPROVED OUTCOMES

An observational study in Premature Ejaculation, sponsored by OZGUR EKICI. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-25.

Sponsored by OZGUR EKICI · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
54
Ages
18 Years to 60 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Premature Ejaculation with a site in Turkey — 3 open to participants now, 3 under way, none of them phase 3. Premature Ejaculation · Turkey.

Started
2024
the only one that year
Observational
4 of 14
1 open now
Registered
7th of 14
by date
Lead sponsor
1 of 14
OZGUR EKICI

Among the 14 studies in Premature Ejaculation with a site in Turkey, this one is the only one that started in 2024, is one of 4 observational ones, and was the 7th registered.

By phase

14 studies; the count open now beside each. This study's row is marked.

No phase8 · 2 open
Observationalthis study4 · 1 open
Phase 42 · 0 open

By the year they started

First in 2016; this study’s year is marked. 1 started in 2024.

What they test

Size and results

Median enrollment 67 across the 10 interventional studies, 102 across the 4 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 14 studies in Premature Ejaculation with a site in Turkey, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Premature Ejaculation

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Keywords

  • premature ejaculation, intravaginal ejaculatory latancy time, premature ejaculation diagnostic tool, vitamin B12, premature ejaculation profile
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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 criteria

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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05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
54 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Interventions

  • Vitamin B12 treatment was initiated in male patients with vitamin B12 deficiency due to anemia etiology.

06

What researchers measure

Primary outcomes

  1. intravaginal ejaculation latency time after treatment

    intravaginal ejaculation latency time after treatment

    Time frame: 6 months

07

Study locations

1 site
  • Bursa City Hospital
    Bursa, Nilufer 16000, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2024 to primary completion in Mar 2025, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2025
First posted
Jun 25, 2025
StartActual
Oct 1, 2024
Primary completionActual
Mar 1, 2025
CompletionActual
May 1, 2025
Last update
Jun 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07036497
Lead sponsor
OZGUR EKICI
Responsible party
OZGUR EKICI (MD, Erzincan Binali Yildirim Universitesi) — Sponsor-investigator
First posted
Jun 25, 2025
Start date
Oct 1, 2024
Primary completion
Mar 1, 2025
Completion
May 1, 2025
Last update
Jun 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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