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Completed

NCT Number: NCT04355949

Assessment of Serum Levels of 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.

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Key information

Conditions

Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Premature Ejaculation Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Sohag University, Egypt

Sohag, 82524, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum vitamin D, vitamin B12, folic acid

Diagnostic Test

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

Other names: Serum vitamin D, vitamin B12, folic acid levels

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Acronym: PE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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