ClinicalTrials.gg
CompletedNCT04355949PEUpdated Jan 11, 2021

Assessment of Serum Levels of Vitamin D, Vitamin B12 and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.

An interventional study of Serum vitamin D, vitamin B12, folic acid in Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation, sponsored by Sohag University. Completed at 1 site in Egypt. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-11.

Sponsored by Sohag University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation

Browse trials for

Keywords

  • Premature Ejaculation
03

In context

Premature Ejaculation

106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.

This study's enrollment of 60 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.

Browse Premature Ejaculation studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • premature ejaculation
  • non-responding to dapoxetine treatment.

Exclusion criteria

Exclusion Criteria:

  • diabetes mellitus,
  • chronic prostatitis,
  • Advanced renal or hepatic diseases
  • neurological diseases and
  • C.N.S. medications
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Patients with premature ejaculation

    Serum vitamin D, vitamin B12, and folic acid levels will be assessed

    Diagnostic Test: Serum vitamin D, vitamin B12, folic acid

  • Experimental
    Normal subjects

    Serum vitamin D, vitamin B12, and folic acid levels will be assessed

    Diagnostic Test: Serum vitamin D, vitamin B12, folic acid

Interventions

  • Diagnostic testSerum vitamin D, vitamin B12, folic acid

    Serum vitamin D, vitamin B12, and folic acid levels will be assessed

    Also known as: Serum vitamin D, vitamin B12, folic acid levels

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-1 week

  2. vitamin B12, in patient with PE

    vitamin B12 levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.

    Time frame: 0-1 week

  3. folic acid in patient with PE

    folic acid levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.

    Time frame: 0-1 week

07

Study locations

1 site
  • Faculty of Medicine, Sohag University, Egypt
    Sohag, 82524, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04355949
Lead sponsor
Sohag University
Responsible party
Mohammed Abu El-Hamd (Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt., Sohag University) — Principal investigator
First posted
Apr 21, 2020
Start date
Feb 28, 2020
Primary completion
May 30, 2020
Completion
Jun 30, 2020
Last update
Jan 11, 2021

Study contacts

Mohammed Abu El-Hamd, MD
principal investigator · Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University

Oversight

Data monitoring committee
Yes
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 Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion