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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04085354
Other study ID # 2/2019
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 10, 2019
Est. completion date August 29, 2019

Study information

Verified date August 2019
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date August 29, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

Premature ejaculation

Exclusion Criteria:

- Erectile dysfunction

- Diabetes mellitus

- chronic prostatitis

- Advanced renal or hepatic diseases

- Neurological diseases

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
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

Locations

Country Name City State
Egypt Faculty of Medicine, Sohag University, Egypt Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Intravaginal ejaculatory latency times By using stopwatches 0-6 weeks after treatment
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