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

Not Applicable

Completed

• Conditions: Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation
• Interventions: Diagnostic Test: Serum vitamin D, vitamin B12, folic acid

• Registration Number: NCT04355949
• Lead Sponsor: Sohag University

Brief 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.

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 Timeline

• Study Start: 2020-02-28
• Study First Submitted: 2020-04-12
• Study First Submitted QC: 2020-04-19
• Study First Posted: 2020-04-21
• Primary Completion: 2020-05-30
• Study Completion: 2020-06-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with premature ejaculation	Serum vitamin D, vitamin B12, folic acid	Serum vitamin D, vitamin B12, and folic acid levels will be assessed
Normal subjects	Serum vitamin D, vitamin B12, folic acid	Serum vitamin D, vitamin B12, and folic acid levels will be assessed

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine, Sohag University, Egypt; 🇪🇬 Sohag, Egypt