A comparative study of the effect of dienogest and OCP on pain associated with endometriosis
Design
A clinical trial with parallel groups without blinding and randomized, phase 3 on 100 patients. Random number generation program will be used for randomization.
Settings and conduct
This clinical trial study will be conducted in Isfahan city at Al-Zahra Hospital on patients diagnosed with endometriosis. The way of working is dividing the patients into two treatment groups and treating them with LD or Dinogest daily for 1 year. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
This study will be conducted on a group of women with a definitive diagnosis of endometriosis. The entry criteria include a definitive diagnosis of endometriosis in ultrasound and informed consent, and the criteria for not entering pregnancy intention and lack of informed consent.
Intervention groups
Patients in this study are divided into two groups. The first group is treated with Dynogest 2 mg tablets made by Aburihan Pharmaceutical Company on a daily basis and once a day for up to 1 year, and the second group is treated with LD tablets made by Aburihan Company on a cyclical basis for up to 1 year and 1 tablet each day.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230509058136N1
Registration date:2023-05-11, 1402/02/21
Registration timing:prospective
Last update:2023-05-11, 1402/02/21
Update count:0
Registration date
2023-05-11, 1402/02/21
Registrant information
Name
Niloofar Ashtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3267 7354
Email address
ashtarimedical@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of Dienogest and OCP on endometriosis-related pain and endometrioma size
Public title
Dienogest and OCPs on endometriosis-related pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 16 to 40
sonography indicating endometriosis
informed consent
no intention of pregnancy
Exclusion criteria:
intention of pregnancy
without informed consent
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done with the help of random number generation program. A number of envelopes were determined according to the number of people in the study, and each sequence of numbers created by the program was placed in each envelope and the envelopes were closed. Then an envelope was opened according to the order of entry of the participants and the number inside was shown. If the production number is odd, the patient is placed in the first group, and if the number is even, the patient is placed in the second group.
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
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.MUI.MED.REC.1401.224
Health conditions studied
1
Description of health condition studied
ENDOMETRIOSIS
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
pain
Timepoint
3 month, 6 month and 12 month after
Method of measurement
visual analoug scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with Dienogest 2 mg tablets made by Aburihan company one per day and daily for up to 1 year.
Category
Treatment - Drugs
2
Description
Intervention group: Treatment with LD drug made by Aburihan company on a daily basis and once a day for up to 1 year
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Niloofar Ashtari
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
ashtarimedical@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saghayegh Haghjoo
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
vcr-office@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Niloofar Ashtari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
ashtarimedical@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Niloofar Ashtari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
ashtarimedical@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Niloofar Ashtari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hezar jarib
City
Hezar Jarib
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
ashtarimedical@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD