This research has been conducted to detect the effect of Simvastatin on the treatment of endometriosis; inhibition of recurrence of endometriotic lesions, decreasing dyspareunia, pelvic pain and dysmenorrhea. Methods: The samples are the women that have laparoscopy and their histological result is endometriosis .Sixty patients will be divided in two groups (Simvastatin and GNRH agonist) in a randomized and double blind manner. In GNRH agonist group 4 doses of Decapeptyle will be injected and Simvastatin group will take one tablet of 20mg Simvastatin per day. Severity of dyspareunia, pelvic pain and dysmenorrhea will be evaluated by Visual Analogue Scale in the day after operation and one month after termination of medical treatment. The patients will have second laparoscopy for evaluation of severity of disease during one month after termination of medical treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009123384N5
Registration date:2010-12-25, 1389/10/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-25, 1389/10/04
Registrant information
Name
Ameneh Ebrahim Valoojerdi
Name of organization / entity
Endocrine research center
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5247
Email address
info@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Simvastatin and gonadotropin-releasing hormone agonist to prevent recurrence of endometriosis
Public title
Effect of Simvastatin on recurrence of endometriosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients who have laparoscopy and their histological result is endometriosis. Exclusion criteria: Patients who don’t like to do laparoscopy or take drug.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemat highway
City
Tehran
Postal code
Approval date
2010-06-13, 1389/03/23
Ethics committee reference number
1707575
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
C54.1
ICD-10 code description
Endometrium
Primary outcomes
1
Description
Recurrence of endometriosis
Timepoint
First & 6 months after treatment
Method of measurement
Laparoscopy
Secondary outcomes
1
Description
severity of dyspareunia
Timepoint
the day after operation and one month after termination of medical treatment
Method of measurement
Visual Analog Scale
2
Description
pelvic pain
Timepoint
the day after operation and one month after termination of medical treatment
Method of measurement
Visual Analog Scale
Intervention groups
1
Description
GNRH agonist group: 4 doses of Decapeptyle injection
Category
Treatment - Drugs
2
Description
Simvastatin group: one tablet of 20mg Simvastatin per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Maziar Moradi
Street address
Hemat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Fariba Almasi
Position
Associate Professor
Other areas of specialty/work
Street address
Hazrat Rasoul hospital, Shahid Mansoori valley, Niayesh St., Sattar Khan St.
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
dralmassi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fariba Almasi
Position
Associate Professor
Other areas of specialty/work
Street address
Hazrat Rasoul hospital, Shahid Mansoori valley, Niayesh St., Sattar Khan St.
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
dralmassi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Ameneh Ebrahim Valoojerdi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)