Premature ejaculation is the most common male sexual dysfunction in worldwide. In recent years SSRIs have been used successfully in the treatment of premature ejaculation and PDE-5I that are also the preferred treatment for erectile dysfunction have been used alone or in combination with an SSRI for the treatment of premature ejaculation by several researchers. This double-blind randomized clinical trial plans to compared the effect of the combination therapy with sertraline and tadalafil on patients with primary premature ejaculation with the combination therapy with sertraline and placebo. All men aged between 18 and 50 years with complaints of premature ejaculation who referred to Razi Hospital and three private clinics in the Gilan Province are divided into two groups. Group A are treated with sertraline 50mg and tadalafil 10mg before intercourse for 6 weeks and group B are treated with sertraline 50mg and placebo before intercourse for 6 weeks. At the end of the study, the mean Intravaginal Ejaculatory Latency Time (IELT) during the last three weeks will be calculated and will be compared with baseline IELT. Also, before and after study Premature Ejaculation Profile questionnaire (PEP) will be completed by the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811101853N7
Registration date:2012-09-15, 1391/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-15, 1391/06/25
Registrant information
Name
Siavash Falahatkar
Name of organization / entity
Urology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
urc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center, Guilan University of Medical Sciences
Expected recruitment start date
2012-04-29, 1391/02/10
Expected recruitment end date
2012-12-30, 1391/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of tadalafil and serteraline cobmination therapy with serteraline and placebo in treatment of premature ejaculation
Public title
The effects of tadalafil and serteraline cobmination therapy in treatment of premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: People who have been married at least for 6 months; Patients who suffer from primary premature ejaculation (PE); Age between 50-18 years
Exclusion criteria: A history of mental illness and physical illness such as liver disease and diabetes Mellitus (DM); Previous surgery on sexual function was affected; Currently abusing alcohol or drug; Patients with secondary PE associated with erectile dysfunction (ED); Contraindications of taking PDEIs
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Science
Street address
Namjoo Street
City
Rasht
Postal code
41448-95655
Approval date
2012-04-26, 1391/02/07
Ethics committee reference number
1910051506
Health conditions studied
1
Description of health condition studied
Premature ejaculation
ICD-10 code
F52.4
ICD-10 code description
Premature ejaculation
Primary outcomes
1
Description
The time from penetration to ejaculation
Timepoint
before and the end of the study
Method of measurement
timer
Secondary outcomes
1
Description
Control over ejaculation
Timepoint
before and the end of the study
Method of measurement
PEP questionnaire
2
Description
Satisfaction
Timepoint
before and the end of the study
Method of measurement
PEP questionnaire
3
Description
Distress
Timepoint
before and the end of the study
Method of measurement
PEP questionnaire
4
Description
problem with partner
Timepoint
before and the end of the study
Method of measurement
PEP questionnaire
Intervention groups
1
Description
Sertraline 50 mg daily with tadalafil 10 mg before intercourse
Category
Treatment - Drugs
2
Description
Sertraline 50 mg daily with placebo before intercourse
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Reza Shahrokhi (Rezident)
Street address
Razi Hospital
City
Rasht
2
Recruitment center
Name of recruitment center
Dr. Gholamreza Mokhtari's clinic
Full name of responsible person
Dr. Gholamreza Mokhtari
Street address
Navab Ave., Golsar Sq., Rasht
City
Rasht
3
Recruitment center
Name of recruitment center
Dr. Iradj Khosropanah's clinic
Full name of responsible person
Dr. Iradj Khosropanah
Street address
Golsar Sq., Rasht
City
Rasht
4
Recruitment center
Name of recruitment center
Dr. Ali Roshani's clinic
Full name of responsible person
Dr. Ali Roshani
Street address
Motahari Ave., Anzali
City
Anzali
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Siavash Falahatkar
Street address
Razi Hospital, Urology Research Center
City
Rasht
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Reza Shahrokhi
Position
Co worker/Resident
Other areas of specialty/work
Street address
Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Gholamreza Mokhtari
Position
Associated Professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Center,Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc1384@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Samaneh Esmaeili
Position
Master/ Researcher of Urology Research Center
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc1384@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)