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 (PE)

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ClinicalTrials.gov Identifier: NCT04085354

Recruitment Status : Completed

First Posted : September 11, 2019

Last Update Posted : September 11, 2019

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Sponsor:

Information provided by (Responsible Party):

Mohammed Abu El-Hamd, Sohag University

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

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Study Type :	Interventional (Clinical Trial)
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).
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 :	February 10, 2019
Actual Primary Completion Date :	June 1, 2019
Actual Study Completion Date :	August 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins Folic Acid

Drug Information available for: Folic acid Cyanocobalamin Vitamin B Complex Cobalamin Hydroxocobalamin

U.S. FDA Resources

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 [ Time Frame: 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 [ Time Frame: 0-6 weeks after treatment ]
By using stopwatches

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 50 Years (Adult)
Sexes Eligible for Study:	Male
Gender Based Eligibility:	Yes
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Premature ejaculation

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085354

Locations

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Egypt
Faculty of Medicine, Sohag University, Egypt
Sohag, Egypt, 82524

Sponsors and Collaborators

Sohag University

Investigators

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

More Information

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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:	September 11, 2019 Key Record Dates
Last Update Posted:	September 11, 2019
Last Verified:	August 2019

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Mohammed Abu El-Hamd, Sohag University:


Premature Ejaculation

Additional relevant MeSH terms:

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Premature Birth Premature Ejaculation Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Ejaculatory Dysfunction Genital Diseases, Male Genital Diseases Sexual Dysfunction, Physiological	Male Urogenital Diseases Sexual Dysfunctions, Psychological Mental Disorders Vitamins Folic Acid Vitamin B 12 Hydroxocobalamin Micronutrients Physiological Effects of Drugs Hematinics Vitamin B Complex

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