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

NCT ID: NCT04355949

Last Updated: 2021-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2020-06-30

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

assess serum levels of vitamin D, vitamin B12 and folic acid among patients with lifelong PE and non-responding to dapoxetine treatment.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators
In a case-controlled clinical study, it will be carried out on 30 patients with lifelong PE and 30 healthy control subjects.

Serum vitamin D, vitamin B12, and folic acid levels will be assessed in all subjects included in the study.

Study Groups

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Patients with premature ejaculation

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

Group Type EXPERIMENTAL

Serum vitamin D, vitamin B12, folic acid

Intervention Type DIAGNOSTIC_TEST

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

Normal subjects

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

Group Type EXPERIMENTAL

Serum vitamin D, vitamin B12, folic acid

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Serum vitamin D, vitamin B12, folic acid

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Serum vitamin D, vitamin B12, folic acid levels

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Abu El-Hamd

Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed Abu El-Hamd, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University

Locations

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Faculty of Medicine, Sohag University, Egypt

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2/2020

Identifier Type: -

Identifier Source: org_study_id

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