Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation

What Was Tested

In this phase 3 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

It had four arms (groups): Placebo (placebo comparator), Dapoxetine (active comparator), Dapoxetine and folic acid. (active comparator) and Dapoxetine and vitamin B12 (active comparator).

Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.

The registry classes the interventions as drug.

More on the Plan

In a single-blind placebo-controlled clinical study, it will be carried out on 120 patients with PE.

All patients will be randomized equally divided into four groups (30 patients each).

Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.

Who Took Part

The registry lists 120 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 0 inclusion and 5 exclusion criteria; among the exclusions: erectile dysfunction; diabetes mellitus; chronic prostatitis.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2019-02-10 with completion listed for 2019-06-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Arabic Index of Premature Ejaculation (time frame: 0-6 weeks after treatment). Intravaginal ejaculatory latency times (time frame: 0-6 weeks after treatment).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 120 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.