Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation: A Randomized Clinical Trial
Phase: PHASE4
Conditions: Premature (Early) Ejaculation
Sponsor: Beni-Suef University

 
 
 
Safety and Efficacy of Dapoxetine compared to Silodosin and Citalopram 
in treatment of premature ejaculation
 
Protocol of Thesis 
 
Submitted For Partial Fulfillment of Master Degree in Urology
 
By
 
Ahmed Mohamed Eid
 
M.B.B.Ch
 
Faculty of Medicine
 
Beni-Suef University
 
Under supervision of
 
Dr. Ahmed Mahmoud  Abdelbary
 
Professor of Urology
 
Faculty of Medicine, Beni-Suef University
 .
 
Dr. Ahmed Elsayed Abdelattif
 
Lecturer of Urology
 
Faculty of Medicine, Beni-Suef University
 
 
 Mahmoud
Dr.Mahmoud Abdallah
 
 
 
Lecturer of Urology
 
Faculty of Medicine, Beni-Suef University                                       
 
2024
 

 
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INTRODUCTION  
Premature ejaculation( PE) is a common sexual problem(1,2). Many 
epidemiological reports have shown that approximately 20–30% of men have 
complaints of PE(3). As prevalence ofintravaginal ejaculation latency time ( IELT ) 
of 1 min is approximately 1–3%(4) . 
its prevalence varies widely depending on definitions of PE and the manner 
in which the prevalence data was gathered.PE is significantly related to high levels 
of distress, low satisfaction with sexual intercourse and reduced sexual self-
confidence and overall quality of life. For female partners, PE is a significant cause 
of distress(5) . 
Treatment for PE has included oral medication, such as SSRI, topical agents 
and behavioraland cognitive therapy(6) . 
Silodosin is a new highly selective a1A-adrenoceptor antagonist, and clinical 
data show significant clinical efficacy for LUTS(7). 
However, in these studies, abnormal ejaculation was found in a relatively higher 
percentage of participants. This suppression of ejaculation by silodosin has been 
confirmed in well-designed studies with volunteers. Furthermore, safety even for 
the elderly was well established in treatment data for LUTS. These 
observationssuggest that silodosin might be effective treatment for PE(8) . 
 
Recently, dapoxetine, a novel fast acting SSRI, was approved for the on-
demand treatment of PE in several countries.However, SSRI have possibleSSRI-
related adverse effects. Although, the safety and efficacy of some treatments for 
PEhave been reported safer and more effective treatment options are still 
required.but have some adverse effects, including postural hypotension and 
ejaculatory dysfunction(9) . 

 
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AIM OF THE Work            
The current study is designed to evaluate effectiveness and safety of 
dapoxetinein treatment of premature ejaculation in compared to silodosin and 
Citalopram in randomized Controlled Study  . 
 

 
 
3 
 
Participants AND METHODS : 
This study will be a randomized controlled study done by sealed 
envelope at the Urology department, Beni-Suef  University Hospital after 
obtaining the approval of the Scientific Research Ethics Committee of the Faculty 
of Medicine, Beni-SuefUniversity (from June 2024 to July 2024).  
3.1. PARTICIPANT:  
The study population will be patients complaining of pre-mature 
ejaculation who will be recruited from Urology department at Beni-
SuefUniversity Hospital. 
 
3.1.1. Sample Size: 
F tests - ANOVA: Fixed effects, main effects and interaction (11) . 
Analysis: 
A priori: Compute required sample size  
Input: Effect size f = 
0.25 
 
α err prob 
= 
0.05 
 
Power (1-β err prob) 
= 
0.95 
 
Numerator df 
= 
10 
 
Number of groups = 
4 
 
Number of covariates 
= 
1 
Output: 
Noncentrality parameter λ 
= 
25.0000000 
 
Critical F 
= 
1.8546920 
 
Denominator df 
= 
395 
 
Total sample size = 
400 
 
Actual power 
= 
0.9504191 

 
 
4 
 
 
 
Participants will be selected according to the following inclusion and 
exclusion criteria: 
3.1.2. Inclusion Criteria: (12) . 
1) Premature Ejaculation (PE) diagnosed by Diagnostic and Statistical 
Manual of Mental Disorders, fourth edition, text revision (DSM-IV-
TR) criteria. 
2) Stable heterosexual, monogamous relationships more than 3 months. 
3) Age of 20 years or older. 
4) Patient acceptance to join the study after signing an informed 
consent. 
3.1.3. Exclusion Criteria : 
1) Patients who received any medication for premature ejaculation 
during the last 4 weeks. 
2)  Patients on sex hormones supplementation. 
3) History of physical or psychological disorder (patient or partner). 
4) Antidepressant therapy, local anesthetic spray, intra-cavernosal 
injection or psychotherapy within 4 weeks. 
5)  History of alcohol or drug abuse. 
6) Hypotensive patients.  
 
 

 
 
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3.2. METHODS 
The 400 subjects were divided into 4 groups: 
• Group A:100 male patients with premature ejaculation Citalopram . 
• Group B:100 male patients with premature ejaculation (on demand) Silodosin 
8 mg. 
• Group C:100  male patients with premature ejaculation (on demand)dapoxtine 
30 mg. 
• Group D : 100 male patints with premature ejaculation  (on 
demand)dapoxetine 60 mg . 
All members of the study were subjected to the following: 
A) A detailed history taking: Demographic data such as age, course, 
duration of the disease, medical history and history of drugs that may 
interact with silodosin or dapoxetine or Citalopram  . 
B) Procedure: 
Participants were randomly assigned to four equal groups (n = 100 each) 
using a computer-generated random s and centralized randomization: 
● Group A: Received Citalopram hydrobromide, starting with 10 mg once 
daily for 1 week, followed by 20 mg once daily for 10 weeks, and 10 mg 
daily during the final week (tapered). 
● Group B: Received Silodosin 4mg, administered orally once daily. 
● Group C: Received Dapoxetine hydrochloride 30 mg, taken 2 hours 
before intercourse, on-demand, minimum of 8 times/month for 3 months. 
● Group D: Received Dapoxetine hydrochloride 30 mg, administered daily. 
 

 
 
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C) Measurements 
 
1ـAll patient in this study willbe evaluated according to IELT, measured using a 
watch (not a stop watch) by the patient. IELT refers to the time between the start 
of vaginal intromission and the start of intravaginal ejaculation or sense of orgasm 
pre- and post-treatment. 
2ـ  All patients in this study were evaluated pre and after treatment according to 
premature ejaculation profile questionnaire (PEPQ) to determine the exact effect 
of the drugs in this study either silodosin or dapoxtine or citalopram . This 
questionnaire, developed by Patrick et al (10).assesses four domains of PE; • 
Perceived control over ejaculation. • Personal distress related to ejaculation. • 
Interpersonal difficulty related to ejaculation. •Satisfaction with sexual 
intercourse. Each domain is assessed by using a single question, and the response 
is rated on a five-point scale from 0–5; higher scores indicate better functioning. 
3.2. STATISTICAL DATA ANALYSIS: 
Numbers and percentages of patients will be given for categorical variables, 
which were then compared across groups using Pearson's Chi-square test. Group 
differences in continuous variables were determined by calculating their 
means±standard deviations, and medians (interquartile range) according to their 
normal distribution; then, using theone way ANOVA or kruskalwallis test 
according to the normality distribution , we compared the groups according to the 
distribution of the scale variables. Pearson's and Spearman's correlations will 
employed in the correlation of continuous variables according to the normality 
distribution. We will use IBM's SPSS version 20 statistical software for our 

 
 
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analysis, and our alpha was set at 5 Percent. Thus, a P value of 0.05 was 
considered statistically significan . 
3.3. ETHICAL CONSIDERATION: 
This study protocol will be revised and approved by the research ethics 
committee of the Faculty of Medicine of Beni-Suef University. The study 
followed the declaration of Helsinki for research ethics standards . 
 

 
 
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