Comparative study on the effects of continuous administration of dienogest and continuous oral contraceptive pills on the recurrence of endometriosis symptoms after laparoscopic surgery
Compare the effects of dinogest and oral contraceptives in reducing the recurrence of endometriosis after endometriosis laparoscopy using questionnaires before surgery and after using the drugs (after surgery)
Design
This study is a two_side_blind randomized clinical trial. The way of sampling is convenience. In this study the patients have undergone laparoscopy for endometriosis are divided into 2 groups accidentally, there are 40 people in each group. One group will receive dinogest and the second group will receive oral contraceptives for 6 months.
Settings and conduct
All interventions are done in Beheshty and Alzahra hospitals. In this study two sided blindness is performed and the evaluator (person who asks and exams the clients after using the drug) does not know which drug is used and the analyser is unaware of the two groups under medication. The data is given to the analyser as separated codes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with 20 to 40 years of age; the tendency in the cooperation with the intervention; with symptoms of endometriosis ; patients referred to Isfahan's Alzahra and Shahid Beheshty hospitals.
Exclusion criteria: Patients whose addresses are changed and they are not available; patients with hormonal therapy three months prior to surgery; having contraindication for oral contraceptives.
Intervention groups
The participants are divided accidentally into two groups. One group will receive dinogest and the other group will receive oral contraceptives continuously after surgery.
Main outcome variables
Recurrence; pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120201008897N7
Registration date:2019-05-02, 1398/02/12
Registration timing:prospective
Last update:2019-05-02, 1398/02/12
Update count:0
Registration date
2019-05-02, 1398/02/12
Registrant information
Name
Safoura Rouholamin
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1236 7001
Email address
s_rouholamin@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-15, 1398/03/25
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the effects of continuous administration of dienogest and continuous oral contraceptive pills on the recurrence of endometriosis symptoms after laparoscopic surgery
Public title
Effects of dienogest and oral contraceptive pills on endometriosis symptoms after laparoscopic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diagnosis endometriosis via laparoscopy
Premenopausal patients
Patients who have symptoms of endometriosis before surgery (eg: dysmenorrhea, dyspareunia, chronic pelvic pain)
Patients who have been referred to Isfahan's Alzhra and Shahid Beheshty hospitals
Patients who do not have any decision for pregnancy during this study
Patients with 20-40 years of age
Exclusion criteria:
Any hormonal therapy 3 months before surgery
Having contraindications for using oral contraceptives
Changing in the address so there is no access to the patient and her information
History of surgery for treatment of endometriosis
History of sexual dysfunction in patient or the partner
Clients who undergo hysterectomy or ouophurectomy during surgery
History of malignancy or heart disease
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization is block type, with blocks of size four. Before assigning the patients to two treatment groups, a container containing the letters A and B is provided with the number of participants with equal beads. The letters indicate the type of the intervention. The beads are drawn out randomly, and this work is continued until the beads are finished. Participant's sequencing is made with the created groups on the sequencing site: http://sealedenvelope.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study the outcome assessor and data analyzer don't know which participant has received dinogest and which one has received oral contraceptives.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
2
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
1417614411
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.MUI.MED.REC.1397.335
Health conditions studied
1
Description of health condition studied
laparoscopy of endometriosis
ICD-10 code
N80.9
ICD-10 code description
Endometriosis, unspecified
Primary outcomes
1
Description
Recurrence of endometriosis
Timepoint
6 months
Method of measurement
visual analog scale, WHO quality of life brief (WHOQOL-BREF) , Female Sexual Function Index (FSFI)
2
Description
pain
Timepoint
6 months
Method of measurement
visual analog scale, WHO quality of life brief ( WHOQOL-BREF), Female sexual function index (FSFI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: group receiving dinogest 2mg/day continuously after surgery for 6 months
Category
Prevention
2
Description
Intervention group 2 : group receiving oral contraceptive (low dose monophasic) every day continuously after surgery for 6 months
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
comparing the effects of dinogest and oral contraceptives in reducing the recurrence of endometriosis after laparoscopy
When the data will become available and for how long
The time of accessibility is a month after publishing the information
To whom data/document is available
The information is available for everyone
Under which criteria data/document could be used
The information is available for everyone and everyone is allowed to do any kind of analyses on them
From where data/document is obtainable
address: University of medical siences, Hezar jarib strees, Darvazeh Shiraz, Isfahan postal code:1417614411 phone:00983136202020 website://alzahra.mui.ac.ir Dr Safoura Rouholamin
What processes are involved for a request to access data/document
The demandant should send her/his name, occupation, field of studying and purpose in an email. The requested information will be sent in a week