- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07036497
- Original Trial
THE IMPACT OF VITAMIN B12 TREATMENT ON EJACULATORY FUNCTIONS IN MEN: SYMPTOMATIC RELIEF AND IMPROVED OUTCOMES (VITAMIN B12)
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 Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nilufer
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Bursa, Nilufer, Turkey, 16000
- Bursa City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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intravaginal ejaculation latency time after treatment
Time Frame: 6 months
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intravaginal ejaculation latency time after treatment
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Ejaculatory Dysfunction
- Mental Disorders
- Genital Diseases, Male
- Male Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Obstetric Labor, Premature
- Obstetric Labor Complications
- Pregnancy Complications
- Sexual Dysfunction, Physiological
- Sexual Dysfunctions, Psychological
- Premature Birth
- Premature Ejaculation
- Physiological Effects of Drugs
- Micronutrients
- Vitamin B Complex
- Vitamins
- Hematinics
- Vitamin B 12
- Hydroxocobalamin
Other Study ID Numbers
- 2024-15/6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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