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

January 7, 2021 updated by: Mohammed Abu El-Hamd, Sohag University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Faculty of Medicine, Sohag University, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • premature ejaculation
  • non-responding to dapoxetine treatment.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Serum vitamin D, vitamin B12, and folic acid levels will be assessed
Other Names:
  • Serum vitamin D, vitamin B12, folic acid levels
Experimental: Normal subjects
Serum vitamin D, vitamin B12, and folic acid levels will be assessed
Diagnostic test: Serum vitamin D, vitamin B12, folic acid
Serum vitamin D, vitamin B12, and folic acid levels will be assessed
Other Names:
  • Serum vitamin D, vitamin B12, folic acid levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum vitamin D in patient with PE
Time Frame: 0-1 week
Serum vitamin D levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
0-1 week
vitamin B12, in patient with PE
Time Frame: 0-1 week
vitamin B12 levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
0-1 week
folic acid in patient with PE
Time Frame: 0-1 week
folic acid levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
0-1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Mohammed Abu El-Hamd, MD, Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2020

Primary Completion (Actual)

May 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

April 12, 2020

First Submitted That Met QC Criteria

April 19, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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