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

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

— PE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355949
• Other study ID #: 2/2020
• Status: Completed
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2021
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Serum vitamin D, vitamin B12, folic acid
Serum vitamin D, vitamin B12, and folic acid levels will be assessed

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Sohag University, Egypt	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-1 week
Primary	vitamin B12, in patient with PE	vitamin B12 levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.	0-1 week
Primary	folic acid in patient with PE	folic acid levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.	0-1 week