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

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).

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.

It had two arms (groups): Patients with premature ejaculation (experimental) and Normal subjects (experimental).

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

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

The registry classes the interventions as diagnostic test.

More on the Plan

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 Took Part

The registry lists 60 actual participants took part.

It was open to men only aged from 20 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Non-responding to dapoxetine treatment.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: diabetes mellitus,; chronic prostatitis,; advanced renal or hepatic diseases.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Cyanocobalamin (Vitamin B12) was given.

Those kept unaware of assignments: investigator.

It started in 2020-02-28 with completion listed for 2020-05-30.

It ran at 1 site in Egypt.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Serum vitamin D in patient with PE (time frame: 0-1 week). vitamin B12, in patient with PE (time frame: 0-1 week). folic acid in patient with PE (time frame: 0-1 week).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.