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

PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

February 10, 2019

Primary Completion Date

June 1, 2019

Study Completion Date

August 29, 2019

Conditions
Premature Ejaculation
Interventions
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.

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.

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.

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

Trial Locations (1)

82524

Faculty of Medicine, Sohag University, Egypt, Sohag

All Listed Sponsors
lead

Sohag University

OTHER

NCT04085354 - 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 | Biotech Hunter | Biotech Hunter