This is a Randomized Clinical Trial on Iranian Male subjects living in Tehran referred to Tehran psychological and Family clinics. 78 patients were selected randomly into three groups (Random assignment). All groups were assessed for intravaginal Latency Ejaculation Time (ILET) before the intervention. In the first group 50mg caffeine was administered on demand on every sexual contact with a single partner (married men with their wives) 2 hours before intercourse for 2 weeks and their ILET was assessed after this period. the second group were trained for conventional squeeze technique and the same assessment was done. The third group received Placebo. ILET was calculated with chronometer and SSQ and GHQ-28 were also assessed at the end of the study.
General information
Acronym
PEC
IRCT registration information
IRCT registration number:IRCT2013091614677N1
Registration date:2013-10-24, 1392/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-24, 1392/08/02
Registrant information
Name
Seyed Hassan Saadat
Name of organization / entity
Baqiatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3250
Email address
saadat350@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiatallah Medical Sciences University
Expected recruitment start date
2013-10-10, 1392/07/18
Expected recruitment end date
2014-04-01, 1393/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of caffeine in comparison to conventional squeeze technique on controlling men with premature ejaculation, a Randomized Controlled Trial
Public title
Effect of on premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
INCLUSION CRITERIA:
All marries men (at least 6 months) patients with active sexual intercourse with diagnosed premature ejaculation based on (ICD-10) and functional premature ejaculation (IELT less than 60 seconds) associated with low desire and sexual partner complaint. Patients with other known organic or psychological disorder or patients with drugs or alcohol abuse were not included.
EXCLUSION CRITERIA:
1-Any other new sexual dysfunction
2- Any other new clinical diagnosis
3- Any other new psychological disorder
4- Use of any drugs rather than Caffeine for PE during the study
5- Use of any antidepressant and psychotropic drug during the study
6- hyper sensitivity to caffeine in any phase of the study
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee Baqiatallah Medical Sciences University
Street address
Mollasadra ave. Vanak Sq.
City
Tehran
Postal code
-
Approval date
2013-01-21, 1391/11/02
Ethics committee reference number
33/2 389 ethic code
Health conditions studied
1
Description of health condition studied
Premature Ejaculation
ICD-10 code
F52.4
ICD-10 code description
The inability to control ejaculation sufficiently for both partners to enjoy sexual interaction.
Primary outcomes
1
Description
Intravaginal Ejaculation Latency Time
Timepoint
every ejaculation for 2 weeks
Method of measurement
Chronometer by Sex Partner
Secondary outcomes
empty
Intervention groups
1
Description
Group 3:
intervention with placebo
in this group identical tablets to Caffeine (without any effective content) are used.
Category
Placebo
2
Description
Group 1: 50mg caffeine was administered on demand on every sexual contact with a single partner (married men with their wives) 2 hours before intercourse for 2 weeks and their ILET was assessed after this period.
Category
Treatment - Drugs
3
Description
Group 2: using conventional squeezing technique. which is taught to each patient individually and the IELT is measured after 2 weeks of practice.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Psychology and Family clinics
Full name of responsible person
Seyed Hassan Saadat
Street address
Baqiatallah Medical Sciences University: South Sheikh Bahaee St., Mollasadra Ave., Vanak Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Behavioral Sciences resaerch Cener
Full name of responsible person
Seyed Hassan Saadat
Street address
Baqiatallah Medical Sciences University: South Sheikh Bahaee St., Mollasadra Ave., Vanak Sq.
City
Tehran
Grant name
Grant code / Reference number
389
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behavioral Sciences resaerch Cener
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research (BMSU)
Full name of responsible person
Dr. Morteza Izadi
Street address
Mollaasadra Ave. Vanak Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research (BMSU)
Proportion provided by this source
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
Baqiatallah Medical Sciences University
Full name of responsible person
Seyed Hassan Saadat
Position
Psychologist , MD; Deputy of Research Department
Other areas of specialty/work
Street address
Baqiatallah Medical Sciences University: South Sheikh Bahaee St., Mollasadra Ave., Vanak Sq.
City
Tehran
Postal code
Phone
+98 21 8248 3250
Fax
Email
saadat350@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiatallah Medical Sciences University
Full name of responsible person
Seyed Hassan Saadat
Position
MD, Psychologist
Other areas of specialty/work
Street address
Baqiatallah Medical Sciences University: South Sheikh Bahaee St., Mollasadra Ave., Vanak Sq.
City
Tehran
Postal code
Phone
+98 21 8248 3250
Fax
Email
Saadat350@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Jafarian Kerman
Position
MD
Other areas of specialty/work
Street address
SSRC- Vesal st. Keshavarz Blvd.
City
Tehran
Postal code
Phone
00
Fax
Email
srjafarian@yahoo.com
Web page address
srjafarian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)