This study was aimed to compare effect of 3 different medications regimens (pentoxifylin, pentoxifylin+LD, LD) on prevention of recurrence of endometriosis pain.
This is a clinical trial performed on 83 patients with the chief complaint of pain (dysmenorrheal /or pelvic pain) after definite diagnosis of endometriosis by laparoscopy. Patients entered the study after simple sampling, and were allocated into 3 groups, treated with pentoxifylin, pentoxifylin + LD and LD alone for 6 months. Pain severity was assessed pre and post intervention by Visual Analogue Scale. In addition, pain was compared between 3 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109087513N1
Registration date:2012-05-02, 1391/02/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-02, 1391/02/13
Registrant information
Name
Hatav Ghasemi Tehrani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 113 4081
Email address
tehrani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences -Research council
Expected recruitment start date
2008-03-01, 1386/12/11
Expected recruitment end date
2009-12-22, 1388/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison study of effectivness of pentoxifyllin and LD in preventing recurrent endometriosis
Public title
Eeffective of pentoxifyllin on recurrence endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosed Laparascopic endometriosis with the clinical symptoms
Exclusion criteria:Refusing the patient of entry to the protocol; The presence of the specific drug side effects
Age
From 25 years old to 28 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
83
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar Jerib Street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8184851153
Approval date
2007-02-10, 1385/11/21
Ethics committee reference number
387228
Health conditions studied
1
Description of health condition studied
Endometriosis of uterus
ICD-10 code
N80
ICD-10 code description
Endometriosis of uterus
Primary outcomes
1
Description
Pain reilief
Timepoint
6months
Method of measurement
Visual Analog Scale(VAS)
2
Description
endometriosis recurrence
Timepoint
after 6 months of follow up
Method of measurement
clinical assessment
Secondary outcomes
empty
Intervention groups
1
Description
We used the visual analog scale (VAS) method for detecting the severity of the possible pain existence before and after the treatment period (the recurrence).Each treatment duration was about 6months.
Each protocol was described clearly for each patient and finally the three groups were constracted as below:
Group one: 800 mgs of Pentoxifyllin in two divided doses (capsules of 400mgs) daily.
Category
Treatment - Drugs
2
Description
Group two: Pentoxifyllin capsules with the same dose plus OCP (LD) one tablet per night, from the third day of the menstrual cycle for 6 months.
Category
Treatment - Drugs
3
Description
Group three: OCP (LD) one tablet per night for21days then 7days rest and repaet it for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mojdeh Ghasemi
Street address
Felezi Bridge-Beheshti Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences-Research Council
Full name of responsible person
Dr. Peyman Adibi
Street address
No.4, Research Building, Isfahan University of Medical Sciences, Hezar jerib St.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences-Research Council
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
Isfahan University of Medical Sciences
Full name of responsible person
Mojdeh Ghasemi
Position
Midwife, Head of Research Office
Other areas of specialty/work
Street address
Research Office, Shahid Beheshti hospital, Flezi Bridge