Protocol summary
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Study aim
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The comparison of treatment with dienogest and contraceptive oral pills on the pain and quality of life in surgery patients with advanced endometriosis
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Design
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This study will perform before and after the surgical procedure in three groups of patients with advanced endometriosis who will receive dienogest and contraceptive pills after surgery. Participants will be randomly assigned to three groups (two intervention groups and a control group). Sample size will be calculated and applied using the sample size calculation formula
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Settings and conduct
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Patients with advanced endometriosis undergoing surgery in the pediatric ward of Rasoul Akram Hospital. After surgery, the patients will be divided into three groups: treatment with dienogest and contraceptive pill (LD) and also a control group. Quality of life (WHOQOL-BREF), VAS, and three-point score questionnaires will be used before and in two stages of post-test and follow-up, 3 and 6 months after surgery, respectively, and then will compare between the three groups.
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Participants/Inclusion and exclusion criteria
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Initial diagnosis of endometriosis and chronic pelvic pain associated with endometriosis in surgery patients, informed consent to study, no pelvic pain originating from other organs
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Intervention groups
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This study was performed before and after the surgical procedure in three groups of patients with advanced endometriosis who received dienogest (2 mg) and contraceptive pills (LD) and also a placebo for the control group after surgery and compared.
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Main outcome variables
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Pain and quality of life in advanced endometriosis in surgery patients
General information
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Reason for update
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Add a control group to study and conduct experiments with three groups
Correction of the realized time of the beginning and end of the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191011045063N1
Registration date:
2020-02-20, 1398/12/01
Registration timing:
registered_while_recruiting
Last update:
2022-02-25, 1400/12/06
Update count:
4
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Registration date
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2020-02-20, 1398/12/01
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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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2019-03-21, 1398/01/01
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Expected recruitment end date
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2019-11-22, 1398/09/01
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Actual recruitment start date
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2018-03-27, 1397/01/07
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Actual recruitment end date
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2020-03-05, 1398/12/15
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Trial completion date
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2020-03-29, 1399/01/10
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Scientific title
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The comparison of treatment with dienogest and contraceptive oral pills on the improvement of pain, and quality of life in surgery patients with advanced endometriosis
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Public title
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The comparison of treatment with dienogest and contraceptive oral pills on the improvement of pain, and quality of life in surgery patients with advanced endometriosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Early diagnosis of endometriosis and chronic pelvic pain associated with endometriosis
Patients with advanced endometriosis who underwent surgery
Age 18 - 45 years
Body mass index (BMI) 18.5 – 29.9 kg/m2;
No gynecological malignancy
No contraindications to OCP or dienogest
No plans of pregnancy in the near
No underlying diseases
Exclusion criteria:
Personal dissatisfaction for inclusion in the study
Patients whose pelvic pain originates from other organs
Use of gonadotropins or other hormones three months before surgery
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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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1-2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
108
Actual sample size reached:
108
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using a simple random method to assign participants to three groups.
Eligible individuals will be randomly divided into three groups using Excel software and RANDBETWEEN command.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not 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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2018-05-05, 1397/02/15
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Ethics committee reference number
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IR.IUMS.FMD..REC.1398.128
Health conditions studied
1
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Description of health condition studied
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Advanced 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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Pain
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Timepoint
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Before surgery, 3 and 6 months after surgery
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Method of measurement
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Pelvic pain and dyspareunia scores are evaluated using the Visual Analogue Scale (VAS) and dysuria and dyschezia using a three-point score questionnire by possible answers to the items were “yes”, “no”, and “a little”.
Secondary outcomes
1
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Description
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Quality of life
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Timepoint
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Before surgery, 3 and 6 months after surgery
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Method of measurement
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Quality of life was measured using WHOQOL-BREF
2
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Description
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Edverse effects of the treatment
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Timepoint
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3 and 6 months after surgery
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Method of measurement
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Questionnaire
3
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Description
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Pain recurrence
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Timepoint
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6 months after surgery
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: The first group will receive the dienogest drug. Dosage of one tablet of 2 mg daily for six months
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Category
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Treatment - Drugs
2
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Description
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Intervention group: The second group will receive contraceptive pills. One tablet daily for six months
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Category
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Treatment - Drugs
3
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Description
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Control group: Placebo
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Category
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Placebo
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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Iran University of Medical Sciences
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Proportion provided by this source
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10
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Public or private sector
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Private
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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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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable