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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: Serum vitamin D, vitamin B12, folic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: assess serum levels of vitamin D, vitamin B12 and folic acid among patients with lifelong PE and non-responding to dapoxetine treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with premature ejaculation<br>Serum vitamin D, vitamin B12, and folic acid levels will be assessed | Diagnostic Test: Serum vitamin D, vitamin B12, folic acid<br>* Serum vitamin D, vitamin B12, and folic acid levels will be assessed<br>* Other names: Serum vitamin D, vitamin B12, folic acid levels;|
| Experimental: Normal subjects<br>Serum vitamin D, vitamin B12, and folic acid levels will be assessed | Diagnostic Test: Serum vitamin D, vitamin B12, folic acid<br>* Serum vitamin D, vitamin B12, and folic acid levels will be assessed<br>* Other names: Serum vitamin D, vitamin B12, folic acid levels;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Ejaculation