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临床试验/NCT04355949
NCT04355949已完成不适用

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

Sohag University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Serum vitamin D in patient with PE

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

盲法说明

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.

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • premature ejaculation
  • non-responding to dapoxetine treatment.

排除标准

  • diabetes mellitus,
  • chronic prostatitis,
  • Advanced renal or hepatic diseases
  • neurological diseases and
  • C.N.S. medications

结局指标

主要结局

Serum vitamin D in patient with PE

时间窗: 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

时间窗: 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

时间窗: 0-1 week

folic acid levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Abu El-Hamd

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

Sohag University

研究点 (2)

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