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

NCT04085354 | Completed Phase 3 DMC

• 1 other identifier: 2/2019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ejaculation

Keywords

Premature Ejaculation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Multi-Vitamin Tablets

Dapoxetine

ACTIVE COMPARATOR

Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.

Drug: Dapoxetine

Dapoxetine and folic acid.

ACTIVE COMPARATOR

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.

Dapoxetine and vitamin B12

ACTIVE COMPARATOR

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

Interventions

Multi-Vitamin Tablets DRUG

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.

Placebo

Dapoxetine DRUG

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.

Dapoxetine

Dapoxetine and folic acid. DRUG

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.

Dapoxetine and folic acid.

Dapoxetine and vitamin B12 DRUG

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

Dapoxetine and vitamin B12

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Premature ejaculation

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine, Sohag University, Egypt

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Geritol; dapoxetine; Folic Acid; Vitamin B 12

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Mohammed Abu El-Hamd, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt.

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

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 11, 2019
• Study Start: February 10, 2019
• Primary Completion: June 1, 2019
• Study Completion: August 29, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-08

Locations

EG (1)