Comparative study of CGRP neuropeptide levels in patients with endometriosis-induced pain treated with Dinoest
Design
Pain is measured with VAS and a basal serum sample is prepared for the peptide and then, according to the physician's diagnosis, they receive 2 mg orally from one of the dinogest options for pain medication. 6 months later, serum samples are collected for CGRP measurement. Be brought. This information will be provided to the patient as the research information is useful in the future treatment process.
Settings and conduct
Patients with endometriosis who did not receive hormone therapy 3 months ago were referred to Rasoul Hospital and have pain due to the disease. Blood is prepared before using dinogest and 6 months after serum consumption, and serum CGRP level and pain are measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
Women aged 18-44 years with pain and suspected endometriosis
Do not take hormonal drugs containing estrogen or progesterone for three months
No pregnancy
Absence of genital or breast cancers
No abnormal vaginal bleeding
No breastfeeding for 3 months
Do not use housing during the last week
No surgery in the last 3 months
No liver problems
No strong history of venous thrombosis or embolism
Body mass index 5 / 18-26
Exclusion criteria for the endometriosis group include:
Has a history of any genital cancer in the pelvic area
Hormone therapy for the past 3 months
Suffering from a variety of systemic diseases
History of endometrial destruction by thermal balloon or resectoscope
Intervention groups
Patients take dinogest for 6 months.
Main outcome variables
intensity and frequency of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220313054264N1
Registration date:2022-06-12, 1401/03/22
Registration timing:registered_while_recruiting
Last update:2022-06-12, 1401/03/22
Update count:0
Registration date
2022-06-12, 1401/03/22
Registrant information
Name
Marziyeh Ajdary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
ajdari.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of CGRP neuropeptide levels in patients with endometriosis pain treated with dienogest
Public title
A comparative study of CGRP neuropeptide levels in patients with endometriosis pain treated with dienogest
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-44 years with pain and suspected endometriosis
Do not take hormonal drugs containing estrogen or progesterone for three months
No pregnancy
Absence of genital or breast cancers
No abnormal vaginal bleeding
No breastfeeding for 3 months
Do not use housing during the last week
No surgery in the last 3 months
No liver problems
No strong history of venous thrombosis or embolism
Body mass index 5 / 18-26
Exclusion criteria:
Has a history of any genital cancer in the pelvic area
Hormone therapy for the past 3 months
Suffering from a variety of systemic diseases
History of endometrial destruction by thermal balloon or resectoscope
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
10
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 Iran University of Medical Sciences
Street address
Sattar Khan - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.IUMS.REC.1401.219
Health conditions studied
1
Description of health condition studied
endometriosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of pain
Timepoint
3 months and 6 months later
Method of measurement
Vas score questionnaire
2
Description
The amount of CGRP neuropeptide
Timepoint
6 months later
Method of measurement
ELISA device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with endometriosis with pain, according to the doctor's diagnosis for drug treatment of pain Dinogen 2 mg per day orally (tablets) (Iran Hormone Company) once a day for 6 months and assess pain and level The CGRP marker is evaluated before and after taking the drug.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital
Full name of responsible person
Dr Marziyeh Ajdary
Street address
Sattar Khan - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6650 9283
Email
ajdari.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hossein Keyvani-Vice Chancellor for Research and Technology, Iran University of Medical Sciences
Street address
Sattar Khan - Hazrat Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6650 9283
Email
ajdari.m@iums.ac.ir
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
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
Iran University of Medical Sciences
Full name of responsible person
Marziyeh Ajdary-Iran University of Medical Sciences