PE: 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

Sponsor

Sohag University (Other)

Overall Status

Completed

CT.gov ID

NCT04085354

Collaborator

(none)

120

Enrollment

Location

Arms

6.6

Actual Duration (Months)

18.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will aim to assess 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: A randomized placebo-controlled clinical trial.

Condition or Disease	Intervention/Treatment	Phase
Premature Ejaculation	Drug: Multi-Vitamin Tablets Drug: Dapoxetine Drug: Dapoxetine and folic acid. Drug: Dapoxetine and vitamin B12	Phase 3

Detailed Description

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.

Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.

Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used.

Primary Purpose:

Treatment

Official Title:

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: A Randomized Placebo-controlled Clinical Trial

Actual Study Start Date :

Feb 10, 2019

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Aug 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.	Drug: Multi-Vitamin Tablets The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
Active Comparator: Dapoxetine Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.	Drug: Dapoxetine The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.
Active Comparator: Dapoxetine and folic acid. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.	Drug: Dapoxetine and folic acid. The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
Active Comparator: Dapoxetine and vitamin B12 Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12	Drug: Dapoxetine and vitamin B12 The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12

Outcome Measures

Primary Outcome Measures

Arabic Index of Premature Ejaculation [0-6 weeks after treatment]
The AIPE questionnaire includes seven questions.Response to each question will be scored on a scale from 1 to 5.
Intravaginal ejaculatory latency times [0-6 weeks after treatment]
By using stopwatches

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Premature ejaculation

Exclusion Criteria:

Erectile dysfunction
Diabetes mellitus
chronic prostatitis
Advanced renal or hepatic diseases
Neurological diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Sohag University, Egypt	Sohag		Egypt	82524

Sponsors and Collaborators

Sohag University

Investigators

Principal Investigator: Mohammed Abu El-Hamd, MD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed Abu El-Hamd, Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt., Sohag University

ClinicalTrials.gov Identifier:

NCT04085354

Other Study ID Numbers:

2/2019

First Posted:

Sep 11, 2019

Last Update Posted:

Sep 11, 2019

Last Verified:

Aug 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohammed Abu El-Hamd, Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt., Sohag University

Premature Ejaculation

Additional relevant MeSH terms:

Premature Birth

Premature Ejaculation

Study Results

No Results Posted as of Sep 11, 2019