Assessing the effect of Mirena IUD in reducing pain and preventing progression of endometriosis
Design
Single-group (before and after) non-randomized phase 2-3 clinical trial on 43 patients affected by endometriosis, with pain caused by the disease (no control group, no blinding)
Settings and conduct
The place of the study is the special endometriosis clinic of Imam Reza Hospital in Mashhad. The study population includes all patients with a definite diagnosis of endometriosis through imaging (transvaginal/transrectal ultrasound or MRI) who have pain caused by endometriosis. Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients referred to endometriosis clinic of Imam Reza Hospital in Mashhad with diagnosis of endometriosis; having pain caused by disease; age of 20-45 years; desire to have contraception; not using NSAID analgesics; body mass index between 18.5 and 27.5 kg/m2.
Exclusion criteria:
Undiagnosed vaginal bleeding; Suspected malignancy in biopsy; Uterine size greater than 10 weeks of gestation; Submucosal leiomyoma or polyp; septic abortion in the last three months
Intervention groups
Intervention group: 43 patients with endometriosis treated by Mirena IUD.
Main outcome variables
Score of pain based on NPRS criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141230020486N6
Registration date:2024-11-13, 1403/08/23
Registration timing:prospective
Last update:2024-11-13, 1403/08/23
Update count:0
Registration date
2024-11-13, 1403/08/23
Registrant information
Name
Leili Hafizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2608
Email address
hafizil@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-04, 1403/10/15
Expected recruitment end date
2025-07-06, 1404/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effects of levonorgestrel-releasing intrauterine system in reducing pain in women with endometriosis
Public title
The effect of Mirena IUD in reducing pain of endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with definitive diagnosis of endometriosis through imaging having pain caused by endometriosis
Regular menstrual periods (between 25 and 35 days)
Not using hormonal therapy for more than 6 months before the study
Desire to have contraception
Not using NSAID analgesics
Body mass index between 18.5 and 27.5 kg/m2 body
Exclusion criteria:
Undiagnosed vaginal bleeding
Chronic diseases (eg liver problems, diabetes or pelvic inflammatory disease)
History of septic abortion in the last three months
Use of hormonal contraception and IUD during the last 3 months
Pregnancy or breastfeeding in the last 3 months
Suspected malignancy in biopsy
Desire to pregnancy
Uterine size greater than 10 weeks of gestation
Submucosal leiomyoma or polyp
History of osteoporosis
Coagulopaties or allergy to progestins
Age
From 20 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
43
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Ghoreshi Bulding, Next to Hoveyzeh Cinema, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-09-16, 1403/06/26
Ethics committee reference number
IR.MUMS.IRH.REC.1403.141
Health conditions studied
1
Description of health condition studied
Endometriosis disease
ICD-10 code
N80.3
ICD-10 code description
Endometriosis of pelvic peritoneum
2
Description of health condition studied
Endometriosis of rectovaginal septum
ICD-10 code
N80.4
ICD-10 code description
Endometriosis of rectovaginal septum and vagina
Primary outcomes
1
Description
Score of dysmenorrhea, based on the Numeric Pain Rating Scale
Timepoint
Measurement of dysmenorrhea score at the beginning of the study (before the intervention) and 6 months after placement of the mirena IUD.
Method of measurement
Based on the Numeric Pain Rating Scale index
2
Description
Score of dyspareunia, based on the Numeric Pain Rating Scale
Timepoint
Measurement of dyspareunia score at the beginning of the study (before the intervention) and 6 months after placement of the mirena IUD.
Method of measurement
Based on the Numeric Pain Rating Scale index
3
Description
Score of dyschezia, based on the Numeric Pain Rating Scale
Timepoint
Measurement of dyschezia score at the beginning of the study (before the intervention) and 6 months after placement of the mirena IUD.
Method of measurement
Based on the Numeric Pain Rating Scale index
4
Description
Score of non-cyclic pelvic pain, based on the Numeric Pain Rating Scale
Timepoint
Measurement of non-cyclic pelvic pain score at the beginning of the study (before the intervention) and 6 months after placement of the mirena IUD.
Method of measurement
Based on the Numeric Pain Rating Scale index
Secondary outcomes
1
Description
Cancer Antigen 125
Timepoint
Measurement of Cancer Antigen 125 at the beginning of the study (before the intervention) and 6 months after placement of the levonorgestrel-releasing intrauterine system (mirena).
Method of measurement
Based on serum CA125 protein level test (U/ml)
Intervention groups
1
Description
Intervention group: Placement of 52 mg levonorgestrel-releasing intrauterine system (Mirena IUD) (releasing 20 micrograms of levonorgestrel in 24 hours), made by Bayer Company, Germany, in the uterine cavity of patients with endometriosis on an outpatient setting in the clinic. The IUD can remain in the uterus for up to 5 years.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Special Endometriosis Clinic, Imam Reza Hospital, Mashhad
Full name of responsible person
Leili Hafizi Lotfabadi
Street address
Ebne Sina Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 21 3802 2000
Email
IRH.p.relations@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Vice Chancellor for Research and Technology, Ghoreshi Bulding, Next to Hoveyzeh Cinema, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Leili Hafizi Lotfabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Olum Blvd., Daneshgah Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3843 0634
Email
hafizil@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Leili Hafizi Lotfabadi
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Olum Blvd., Daneshgah Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3843 0634
Email
hafizil@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Leili Hafizi Lotfabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Olum Blvd., Daneshgah Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3843 0634
Email
hafizil@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after making individuals unidentifiable
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Mention the source
From where data/document is obtainable
Dr. Leili Hafizi / Email: hafizil@mums.ac.ir / Phone: 09153107633
What processes are involved for a request to access data/document