The comparison of treatment with dienogest and contraceptive oral pills on the improvement of Dysmenorrhea, and quality of life in surgery patients with advanced endometriosis
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Protocol summary
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of Dysmenorrhea, and quality of life in surgery patients with advanced endometriosis
The comparison of treatment with dienogest and contraceptive oral pills on the pain and quality of life in surgery patients with advanced endometriosis
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of Dysmenorrhea,pain and quality of life in surgery patients with advanced endometriosis
مقایسه اثر درمان داینوجست وقرصهای پیشگیری از بارداری بر دیسمنوره وکیفیت زندگی در بیماران آندومتریوزپیشرفته جراحی شده
مقایسه اثر درمان داینوجست وقرصهای پیشگیری از بارداری بر درد و کیفیت زندگی در بیماران آندومتریوز پیشرفته جراحی شده
مقایسه اثر درمان داینوجست وقرصهای پیشگیری از بارداری بر دیسمنوره وکیفیتدرد و کیفیت زندگی در بیماران آندومتریوزپیشرفتهآندومتریوز پیشرفته جراحی شده
This study was performed before and after the surgical procedure in three groups of patients with advanced endometriosis who received dienogest and contraceptive pills and also a control group after surgery and compared.
This study was performed before and after the surgical procedure in three groups of patients with advanced endometriosis who received dienogest and contraceptive pills and also a placebo for the control group after surgery and compared.
This study was performed before and after the surgical procedure in three groups of patients with advanced endometriosis who received dienogest and contraceptive pills and also a placebo for the control group after surgery and compared.
گروه مداخله یک:داروی داینوجست
گروه مداخله دو:قرصهای پیشگیری از بارداری
گروه کنترل
گروه مداخله یک:داروی داینوجست
گروه مداخله دو:قرصهای پیشگیری از بارداری
گروه کنترل پلاسبو
گروه مداخله یک:داروی داینوجست گروه مداخله دو:قرصهای پیشگیری از بارداری گروه کنترل پلاسبو
Primary outcomes
#1
Dysmenorrhea
pain
Dysmenorrheapain
ديسمنوره
درد
ديسمنورهدرد
Intervention groups
#1
empty
Placebo
placebo
empty
Control group: Placebo
Control group: Placebo
empty
گروه کنترل: پلاسبو
گروه کنترل: پلاسبو
Protocol summary
Study aim
The comparison of treatment with dienogest and contraceptive oral pills on the pain and quality of life in surgery patients with advanced endometriosis
Design
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
Settings and conduct
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 and VAS 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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
This study was performed before and after the surgical procedure in three groups of patients with advanced endometriosis who received dienogest and contraceptive pills and also a placebo for the control group after surgery and compared.
Main outcome variables
dysmenorrhea and quality of life in advanced endometriosis in surgery patients
General information
Reason for update
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
Acronym
IRCT registration information
IRCT registration number:IRCT20191011045063N1
Registration date:2020-02-20, 1398/12/01
Registration timing:registered_while_recruiting
Last update:2020-08-16, 1399/05/26
Update count:4
Registration date
2020-02-20, 1398/12/01
Registrant information
Name
Gelareh Niakan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8807 1886
Email address
g.niakan59@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
2018-03-27, 1397/01/07
Actual recruitment end date
2020-03-05, 1398/12/15
Trial completion date
2020-03-29, 1399/01/10
Scientific title
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of Dysmenorrhea, and quality of life in surgery patients with advanced endometriosis
Public title
The comparison of treatment with dienogest and contraceptive oral pills on the improvement of Dysmenorrhea, and quality of life in surgery patients with advanced endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Early diagnosis of endometriosis and chronic pelvic pain associated with endometriosis
patients with advanced endometriosis who underwent surgery
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
Age
No age limit
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
74
Actual sample size reached:
74
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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 Iran University of Medical Sciences
Street address
shahrake gharb
City
Tehran
Province
Tehran
Postal code
1467864184
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.IUMS.FMD..REC.1398.128
Health conditions studied
1
Description of health condition studied
Advanced endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
pain
Timepoint
Pre-test a day before surgery - Post-test 3 months after surgery - Follow-up 6 months after surgery
Method of measurement
Patients are evaluated for visual symptoms (dysmenorrhea, dyspareunia, pelvic pain, and dysuria) using the Visual Analogue Scale (VAS).
2
Description
Quality of life
Timepoint
Pre-test a day before surgery - Post-test 3 months after surgery - Follow-up 6 months after surgery
Method of measurement
A QOL questionnaire is used to assess the quality of life.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group will receive the dienogest drug. Dosage of one tablet of 2 mg daily for six months
Category
Treatment - Drugs
2
Description
Intervention group: The second group will receive contraceptive pills. One tablet daily for six months
Category
Treatment - Drugs
3
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Gelareh Niakan
Street address
No. 7, Falamak shomali Ave.,shahrake gharb
City
Tehran
Province
Tehran
Postal code
1467864184
Phone
+98 21 8807 1886
Email
g.niakan59@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gelareh Niakan
Street address
Shahrake gharb
City
Tehran
Province
Tehran
Postal code
1467864184
Phone
+98 21 8807 1886
Email
g.niakan59@gmail.com
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
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gelareh Niakan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shahrak gharb
City
Tehran
Province
Tehran
Postal code
147864184
Phone
+98 21 8807 1886
Email
g.niakan59@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadeh
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shahrak gharb
City
Tehran
Province
Tehran
Postal code
1467864184
Phone
+98 21 8807 1886
Email
g.niakan59@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gelareh Niakan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
shahrak gharb
City
tehran
Province
Tehran
Postal code
1467864184
Phone
+98 21 8807 1886
Email
g.niakan59@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