Dapoxetine, Silodosin, and Citalopram for Premature Ejaculation
Oral intake of medication
Urogenital Diseases+11
+ Genital Diseases
+ Ejaculatory Dysfunction
Treatment Study
Summary
Study start date: June 1, 2024
Actual date on which the first participant was enrolled.This clinical trial aims to compare the safety and effectiveness of four medications in treating premature ejaculation (PE) in men. The study involves Citalopram, Silodosin, and two different regimens of Dapoxetine. The goal is to find out which medication works best in increasing the time it takes for ejaculation during intercourse, as well as improving control over ejaculation and overall sexual satisfaction. This research is important as it seeks to provide better treatment options for men experiencing PE, a condition that can affect personal relationships and quality of life. Participants in this study are randomly assigned to one of the four treatment groups, each receiving one of the specified medications. These medications are administered either as a daily dose or on demand, depending on the group. The effectiveness of each treatment is measured by changes in the time to ejaculation and improvements in control and satisfaction, using a specific questionnaire designed for this purpose. Additionally, any side effects experienced by participants are carefully monitored and analyzed. This approach helps to ensure the treatments are not only effective but also safe for use.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.450 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Diagnosis of PE according to Premature Ejaculation Profile Questionnaire (PEPQ) and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR)\[12\]. * Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline) * Inability to delay ejaculation during all or nearly all vaginal penetrations * Negative personal consequences (distress, frustration, avoidance of sexual intimacy) * PEPQ score ≥11. * Age ≥ 20 years. * In a stable, monogamous, heterosexual relationship for at least 3 months. * Signed informed consent indicating willingness to participate. Exclusion Criteria: * Use of PE medications in the preceding 4 weeks. * Use of hormonal supplements. * Patients with erectile dysfunction diagnosed by International Index of Erectile Function. * History of psychiatric or significant physical disorders (in either patient or partner). * Use of antidepressants, local anesthetic sprays, intracavernosal injections, or psychotherapy within 4 weeks. * Alcohol or substance abuse. * Documented hypotension.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
Active ComparatorGroup IV
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location