Protocol summary
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Study aim
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effect of dopamine agonists (cabergoline) on pain reduction in endometriosis patients.
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Design
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A clinical trial with control and parallel groups, randomized, phase 3 on 72 patients. The permutation blocks method produced the sequence of randomly allocated people to the studied groups. A random allocation sequence of people was done using Random Allocation Software and a block size of four.
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Settings and conduct
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patients with endometriosis who refer to the gynecology clinic of Ghaem and Imam Reza (AS) hospitals are included in the study based on inclusion and exclusion criteria. Before starting treatment, on the first day of menstruation, the severity of dysmenorrhea pain in patients is measured using the VAS standard.
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Participants/Inclusion and exclusion criteria
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inclusion criteria: Diagnosis of clinical endometriosis by observing pain and tenderness in the pelvic examination along with endometriosis nodules in the vaginal examination, firm and motionless uterus and confirmed by ultrasound or MRI (observation of endometriosis cysts and nodules)
Diagnosis of grade I-IV endometriosis based on r-ASRM criteria during diagnostic laparoscopy during the previous 12 months
Dysmenorrhea complaints with EAPP score >30 or >40, normal pap smear. Exclusion criteria: endometriosis who were treated with GnRH agonist less than 6 months ago, or danazol or progesterone pills less than 3 months ago, or birth control pills less than 1 month ago.
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Intervention groups
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Patients with endometriosis will be given dopamine agonists (cabergoline) 0.5 twice a week for three months and in Contol groups will be given the dingiest 2 milligrams once a day for three months.
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Main outcome variables
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EAPP on the first day of menstruation and at the end of the first, second, and third month is treatment.
General information
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Reason for update
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In practice, changes were made to the exclusion criteria, and the study was conducted double-blind.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181030041503N6
Registration date:
2022-12-20, 1401/09/29
Registration timing:
prospective
Last update:
2024-12-15, 1403/09/25
Update count:
1
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Registration date
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2022-12-20, 1401/09/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-09-23, 1401/07/01
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Expected recruitment end date
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2023-06-22, 1402/04/01
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Actual recruitment start date
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2022-12-22, 1401/10/01
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Actual recruitment end date
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2023-12-22, 1402/10/01
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Trial completion date
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empty
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Scientific title
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the effect of dopamine agonists (cabergoline) on reducing pain in endometriosis patients
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Public title
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the effect cabergoline on reducing pain in endometriosis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of clinical endometriosis by observing pain and tenderness in the pelvic examination along with endometriosis nodules in the vaginal examination, firm and motionless uterus and confirmed by ultrasound or MRI (observation of endometriosis cysts and nodules)
Diagnosis of grade I-IV endometriosis based on r-ASRM criteria during diagnostic laparoscopy during the previous 12 months
Dysmenorrhea complaint with EAPP score >30 or >40
Normal pap smear
Exclusion criteria:
Endometriosis treated less than 6 months ago with a GNRH agonist or less than 3 months ago danazol or progesterone tablets or less than 1 month ago with oral contraceptives.
Severe pain unrelieved by Cabergoline necessitating the use of other analgesics
lack of willingness to continue in the study
non-adherence to the treatment regimen
any adverse reactions to the medication (particularly allergies)
Sensitivity to the medication and incorrect medication intake in the control group
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
80
Actual sample size reached:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, the permutation blocks method was used to generate the sequence of random assignments of people to the studied groups. A random allocation sequence of people was done using Random Allocation Software and a block size of four. The permutation block method is one of the random allocation methods in which each block is selected as an integer multiple of the number of studied groups. In this study, there are four blocks: AABB, ABAB, BBAA, and BABA. One of the blocks is randomly selected. If the first block, AABB, is selected, the first and second person will be assigned to group A, and the third and fourth person will be assigned to group B. And this process continues until all samples are allocated. The feature of this method is that the two study groups will have equal numbers. Random Allocation Software is free software for creating a random sequence using scientific methods including the permutation block method for allocating subjects to treatment groups, which was developed by Dr. Mahmoud Saghaei (https://www.saghaei.net).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The patient is unaware of the treatment, patients are coded A and B based on random assignment, and the researcher gives the drug to the patient based on patient code A or B. The statistical consultant who analyzes the
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-07-02, 1401/04/11
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Ethics committee reference number
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IR.MUMS.REC.1401.158
Health conditions studied
1
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Description of health condition studied
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Endometriosis
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ICD-10 code
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N80
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ICD-10 code description
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Endometriosis
Primary outcomes
1
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Description
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Severe dysmenorrhea pain
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Timepoint
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On the first day of menstruation and at the end of the first, second and third month of treatment
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Method of measurement
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By 10-point visual analogue scale (VAS)
Intervention groups
1
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Description
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Intervention group: Patients with endometriosis who will be given dopamine agonists (cabergoline) 0.5 milligrams twice a week for three months.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients with endometriosis who will be given dingiest 2 milligrams once a day for three month.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available