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Comparison of the effectiveness of Dienogest with medroxyprogesterone acetate in the treatment of pelvic pain and recurrence after laparoscopic surgery in patients with endometriosis

Protocol summary

Study aim
Comparison of the effectiveness of Dienogest with medroxyprogesterone acetate in the treatment of pelvic pain and recurrence of endometriosis after laparoscopic surgery
Design
Study Design: Single blinded phase 3 randomized clinical trial with parallel groups Study groups: 130 eligible women with endometriosis who underwent laparoscopic surgery will be randomly divided into two groups via the block randomization method.
Settings and conduct
After obtaining written consent, a questionnaire containing the required information, blood test, and vaginal ultrasound will be performed for eligible individuals. Dysmenorrhea, dyspareunia, and pelvic pain will be measured with a visual analog scale (VAS). Participants will be randomly divided into two groups: dienogest and medroxyprogesterone acetate. Three months after the intervention, pain, and side effects in both groups will be measured via VAS and a questionnaire. Six months after the intervention, the outcome variables will be re-assessed. The researcher and statistician will be unaware of how the interventions are allocated.
Participants/Inclusion and exclusion criteria
In this study, women aged 18 to 45 years with a laparoscopically confirmed endometriosis will be included. In the case of pregnancy, lactation, amenorrhea, vaginal bleeding, progesterone contraindication, oophorectomy, or hysterectomy during the study and use of some drugs (is described in the relevant section) will be excluded from the study.
Intervention groups
Group 1: Dienogest tablets will be taken daily for 3 months and then cyclically for the next 3 months (every month from day 10 of the cycle for 2 weeks) Group 2: Medroxyprogesterone acetate 10 mg twice daily for 3 months and then cyclically for the next 3 months (every month from day 10 of the cycle for 2 weeks)
Main outcome variables
Recurrence of endometriosis; Pelvic pain; Dysmenorrhea; Dyspareunia; side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170917036227N5
Registration date: 2020-12-16, 1399/09/26
Registration timing: prospective

Last update: 2020-12-16, 1399/09/26
Update count: 0
Registration date
2020-12-16, 1399/09/26
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
mvahid@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Dienogest with medroxyprogesterone acetate in the treatment of pelvic pain and recurrence after laparoscopic surgery in patients with endometriosis
Public title
Comparison of Dienogest with medroxyprogesterone acetate in the treatment of pelvic pain and recurrent endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-45 years old Endometriosis confirmation via laparoscopy and histopathologic assessmnet
Exclusion criteria:
Pregnancy or Breast Feeding Plan to become pregnant Amenorrhea (no more menstruation - equal to 3 months in the last 6 months) Undiagnosed genital bleeding Recent use of hormonal agents Contraindications to the use of progesterone Having a risk factor for decreased bone density Use of acitretin, anticoagulants such as warfarin, antidiabetic drugs, aperitif and, artemether, atazanavir, barbiturates, bexarotene, Boceprevir, bosentan, thrombogenic drugs, clobazam, anticonvulsant drugs (carphenazine, Topiramate, valproic acid, lamotrigine, phenytoin ...), Darunavir, Deferasirox, Efavirenz, Felbamate, Griseofulvin, Mifepristone, Nelfinavir, Neuruppin, Selegiline, Thalidomide, Tranexamic Acid and Voriconazole
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 130
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method will be designed by an epidemiologist using STATA version 13 software. The size of blocks considered will be 4.
Blinding (investigator's opinion)
Single blinded
Blinding description
The randomization list will be solely available to the epidemiologist. To hide the random allocation process, 130 card sequences of treatments will be written accordingly, and then the cards will be placed inside sealed envelopes. A 10-digit random code will be written on each packet as the patient's identification number. When the physician announces the eligibility of a patient, the nurse will provide the envelope and the type of treatment will be selected based on the type mentioned in the envelope. Data analysis will be performed by a statistician who is unaware of all processes performed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Floor 6; Vice Chancellor of Research and Technology; Qods street; Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-12-01, 1399/09/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.825

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis

Primary outcomes

1

Description
Recurrence of endometriosis
Timepoint
Six months after the start of the intervention
Method of measurement
Transvaginal ultrasound

2

Description
Pelvic pain
Timepoint
Three and six months after the start of the intervention
Method of measurement
Visual Analog Scale (VAS)

3

Description
Dysmenorrhea
Timepoint
Three and six months after the start of the intervention
Method of measurement
Visual Analog Scale (VAS)

4

Description
Dyspareunia
Timepoint
Three and six months after the start of the intervention
Method of measurement
Visual Analog Scale (VAS)

5

Description
Side effects
Timepoint
Three and six months after the start of the intervention
Method of measurement
check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Dienogest tablets will be taken daily for 3 months and then cyclically for the next 3 months (every month from day 10 of the cycle for 2 weeks)
Category
Treatment - Drugs

2

Description
Intervention group 2: Medroxyprogesterone acetate 10 mg twice daily for 3 months and then cyclically for the next 3 months (every month from day 10 of the cycle for 2 weeks)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Dr. Reihaneh Hossein
Street address
Rashid street; Tehranpars; Resalat highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Email
hosparash@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Floor 6; Vice Chancellor of Research and Technology; Qods street; Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Haniyeh Roodi
Position
Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash women's hospital, Rashid Ave,Tehranpars, Reslat highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
behroozmoogooie@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Vahid Dastjerdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash women's hospital, Rashid Ave,Tehranpars, Reslat highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
mvahid@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Haniyeh Roodi
Position
Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash women's hospital, Rashid Ave,Tehranpars, Reslat highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
behroozmoogooie@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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