Comparative study on the efficacy of add-on sertraline or dapoxetine to PDE-5 inhibitors (phosphodiesterase type 5) on the erectile function and intra-vaginal ejaculation latency time (IELT) among patients with concomitant erectile dysfunction and premature ejaculation
Determining the effectiveness of adding sertraline and dapoxetine (phosphodiesterase inhibitors type 5) on erectile function and latent and intravaginal ejaculation time in patients with concomitant erectile dysfunction and premature ejaculation
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, phase-3 on 50 patients. SPSS software was used for randomization.
Settings and conduct
This double-blind clinical trial study was performed in 1400 in psychiatric therapists of Khorshid Hospital in Isfahan. In this study, the patient and the person examining the outcome of the treatment will be unaware of the type of medication received by patients.
Participants/Inclusion and exclusion criteria
In this study, patients with erectile dysfunction and premature ejaculation are included in the study. Patients with genitourinary tract infection, neurological disorders and underlying diseases, and people with Selective Serotonin Reuptake Inhibitors (SSRI) allergies or a history of pelvic surgery will not be included in the study.
Intervention groups
50 patients with sexual dysfunction are distributed in two groups of 25 people. The first group will receive 60 mg of dapoxetine one to three hours before sexual activity, and the second group will receive 50 mg of sertraline twice daily for one month. This will continue for 3 months. Then, the duration of intravaginal ejaculation in all individuals (average time in at least three sexual intercourses), at the beginning of the study and also in weeks 4, 8 and 12 after starting the drug by the spouse from the time of vaginal penetration to the time of ejaculation with a stopwatch will be measured.
Main outcome variables
Erectile function, Premature ejaculation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150913024006N5
Registration date:2021-03-02, 1399/12/12
Registration timing:prospective
Last update:2021-03-02, 1399/12/12
Update count:0
Registration date
2021-03-02, 1399/12/12
Registrant information
Name
Mitra Molaeinezhad
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2135
Email address
m_molaei@bsrc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-03, 1400/01/14
Expected recruitment end date
2022-03-18, 1400/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the efficacy of add-on sertraline or dapoxetine to PDE-5 inhibitors (phosphodiesterase type 5) on the erectile function and intra-vaginal ejaculation latency time (IELT) among patients with concomitant erectile dysfunction and premature ejaculation
Public title
The effect of adding sertraline to dapoxetine in relieving sexual problems in men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Erectile dysfunction anda score above 20 in the International index of Erectile Function
Treatment with phosphodiesterase 5 inhibitors (such as Sildenafil, Tadalafil) more than three months before the start of the study
Living in a stable and heterosexual relationship and intention for maintaining the relationship until the end of the study period
Possibility of sexual intercourse at least once a week
Exclusion criteria:
ُSensitivity to Selective Serotonin Reuptake Inhibitors(SSRI) drugs
Urinary tract infections
Neurological disorders
History of pelvic surgery
Underlying diseases such as diabetes, heart disease, hypertension, thyroid disorder
Use of psychiatric drugs
Alcohol consumption
Age
From 18 months old to 80 months old
Gender
Male
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization patients in the two groups simple randomization is used. For this purpose, 50 pieces of paper with the letter A written on 25 of them and the letter B written on the other 25 pieces are poured into the box. Each patient is asked to take a sheet out of the box when entering the study. Depending on what is written on the sheet, the patient enters the first group (A) or the second group (B).
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed by two-blind method. Medications in similar packages prepared by the pharmaceutical company are provided by the researcher to patients who are unaware of the contents of the packages. The outcome of treatment is also assessed by another psychiatrist who is unaware of the type of medication the patient is receiving.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Research faculty, Isfahan University of Medical Sceices, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2020-05-19, 1399/02/30
Ethics committee reference number
IR.MUI.MED.REC.1399.766
Health conditions studied
1
Description of health condition studied
Erectile dysfunction
ICD-10 code
N52
ICD-10 code description
Male erectile dysfunction
Primary outcomes
1
Description
Erectile function
Timepoint
Before the intervention and 4, 8, 12 weeks after the start of the intervention
Method of measurement
Erectile Performance Index Questionnaire
2
Description
Premature ejaculation
Timepoint
Before the intervention and 4, 8, 12 weeks after the start of the intervention
Method of measurement
The interval between the beginning of sexual intercourse and the time of ejaculation in minutes in the before the intervention and 4, 8, 12 weeks after the start of the intervention
Secondary outcomes
1
Description
Premature ejaculation
Timepoint
Before the intervention and 4, 8, 12 weeks after the start of the intervention
Method of measurement
The interval between the beginning of sexual intercourse and the time of ejaculation in minutes
Intervention groups
1
Description
Intervention group 1: This group of patients take a 60 mg oral tablet of dapoxetine made by Exir Pharmaceutical Company one to three hours before the start of sexual activity with the maximum allowed dose for 24 hours.
Category
Treatment - Drugs
2
Description
Intervention group 2: This group takes a 50 mg Sertraline tablet made by Osweh Pharmaceutical Company twice a day for a month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry clinic, Noor hospital
Full name of responsible person
Niloufar Kiani
Street address
Psychatri clinic, Noor hospital, Ostandari street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
kiani1357@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research faculty, Isfahan University of Medical Science, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Niloufar kiani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of psychology, Noor hospital, Ostandari street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
kiani1357@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mitra Molaeinejad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of psychology, Noor hospital, Ostandari street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
M_molaei@bsrc.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research faculty,school of medicine, Isfahan University of Medical Sceinces, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
al.mehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The plan belongs to a government agency and cannot be shared.