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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04085354
Recruitment Status : Completed
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammed Abu El-Hamd, Sohag University

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

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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


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




Primary Outcome Measures :
  1. 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.

  2. Intravaginal ejaculatory latency times [ Time Frame: 0-6 weeks after treatment ]
    By using stopwatches



Information from the National Library of Medicine

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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

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
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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
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Vitamins
Folic Acid
Vitamin B 12
Hydroxocobalamin
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Vitamin B Complex