NCT07036497

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

June 17, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • intravaginal ejaculation latency time after treatment

    intravaginal ejaculation latency time after treatment

    6 months

Interventions

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

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

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 \-

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Nilufer, 16000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

October 1, 2024

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations