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)

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

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.

Study Overview

• Status: Completed
• Conditions: Premature Ejaculation
• Intervention / Treatment: Drug: Multi-Vitamin Tablets; Drug: Dapoxetine; Drug: Dapoxetine and folic acid.; Drug: Dapoxetine and vitamin B12

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

Premature ejaculation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Mohammed Abu El-Hamd, MD, Assistant professor

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2019
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): August 29, 2019

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: September 7, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Premature Ejaculation
• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Premature Ejaculation; Physiological Effects of Drugs; Micronutrients; Vitamin B Complex; Hematinics; Vitamins; Folic Acid; Vitamin B 12; Hydroxocobalamin
• Other Study ID Numbers: 2/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No