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)

Sohag University

Status and phase: Completed; Phase 3

Conditions: Premature Ejaculation

Treatments: Drug: Dapoxetine and folic acid.; Drug: Dapoxetine; Drug: Dapoxetine and vitamin B12; Drug: Multi-Vitamin Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04085354

2/2019

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Premature ejaculation

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Multi-Vitamin Tablets

Dapoxetine

Active Comparator group

Description:

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

Treatment:

Drug: Dapoxetine

Dapoxetine and folic acid.

Active Comparator group

Description:

Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.

Treatment:

Drug: Dapoxetine and folic acid.

Dapoxetine and vitamin B12

Active Comparator group

Description:

Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12

Treatment:

Drug: Dapoxetine and vitamin B12