Back to resultsAssessment of Serum Levels of Vitamin D, Vitamin B12 and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment. (PE)
Primary Purpose
Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Serum vitamin D, vitamin B12, folic acid
Sponsored by
About this trial
This is an interventional diagnostic trial for Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation focused on measuring Premature Ejaculation
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Sohag University, Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients with premature ejaculation
Normal subjects
Arm Description
Serum vitamin D, vitamin B12, and folic acid levels will be assessed
Serum vitamin D, vitamin B12, and folic acid levels will be assessed
Outcomes
Primary Outcome Measures
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.
vitamin B12, in patient with PE
vitamin B12 levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
folic acid in patient with PE
folic acid levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04355949
Brief Title
Assessment of Serum Levels of Vitamin D, Vitamin B12 and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Acronym
PE
Official Title
Vitamin D, Vitamin B12, and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation
Keywords
Premature Ejaculation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with premature ejaculation
Arm Type
Experimental
Arm Description
Serum vitamin D, vitamin B12, and folic acid levels will be assessed
Arm Title
Normal subjects
Arm Type
Experimental
Arm Description
Serum vitamin D, vitamin B12, and folic acid levels will be assessed
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum vitamin D, vitamin B12, folic acid
Other Intervention Name(s)
Serum vitamin D, vitamin B12, folic acid levels
Intervention Description
Serum vitamin D, vitamin B12, and folic acid levels will be assessed
Primary Outcome Measure Information:
Title
Serum vitamin D in patient with PE
Description
Serum vitamin D levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Time Frame
0-1 week
Title
vitamin B12, in patient with PE
Description
vitamin B12 levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Time Frame
0-1 week
Title
folic acid in patient with PE
Description
folic acid levels will be assessed Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Time Frame
0-1 week
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients with lifelong premature ejaculation and non-responding to dapoxetine treatment.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Abu El-Hamd, MD
Organizational Affiliation
Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Sohag University, Egypt
City
Sohag
ZIP/Postal Code
82524
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Serum Levels of Vitamin D, Vitamin B12 and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
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