Comparison of the effect of Dienogest and continuous Combined Oral Contraceptive(COC) in reduction of pelvic pain
Design
Clinical trial on two groups, with parallel groups, on 126 patients, manual randomization. Easy sampling
Settings and conduct
study is conducted on women referring to Endometriosis Center at Taleghani University Hospital to investigate a more effective drug for reducing pain caused by endometriosis.
patients were entered into study by easy sampling and randomized block into 26 groups of 5 and placed in two groups of taking Verogest and continuous oral contraceptive pills.
first group is treated with Verogest 2 mg tablets every night for 180 days and the second group is treated with oral contraceptive pills containing 03.0 micrograms of ethinyl estradiol and 2 mg dinogest every night an effective drug for 180 days. Then, on 30th day, 90th day, and 180th day, patients are evaluated in terms of amount of pain reduction.
Participants/Inclusion and exclusion criteria
inclusion conditions: Women in between 18 to 45 years who are known to have endometriosis and diagnosed with endometriosis radiologically by a skilled sonographer, with endometriosis mapping sonography or MRI or have been confirmed by surgery and mention symptom of moderate to severe pelvic pain.
exclusion criteria: presence of symptoms related to pelvic infections
Pap smear or abnormal pelvic pathology
contraindications to the use of hormonal drugs
pregnancy
Intervention groups
people with endometriosis are divided into two groups, and one group is treated with Verogest and other group is treated with oral contraceptives, and reduction of pelvic pain in these two groups is investigated.
Main outcome variables
severity of pelvic pain caused by endometriosis, including dysmenorrhea and dyspareunia, and chronic pelvic pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241010063323N1
Registration date:2025-10-26, 1404/08/04
Registration timing:registered_while_recruiting
Last update:2025-10-26, 1404/08/04
Update count:0
Registration date
2025-10-26, 1404/08/04
Registrant information
Name
Aida Mazloomi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 301 6106
Email address
idaluxurious@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Dienogest and continuous Combined Oral Contraceptive(COC) in reduction of pelvic pain in endometriosis
Public title
effect of Dienogest in reduction of pelvic pain in endometriosis; continuous Combined Oral Contraceptive(COC) in pelvic pain of endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
known case of endometriosis, and the diagnosis of endometriosis disease has been radiologically confirmed by the center's skilled sonographer with endometriosis mapping sonography or MRI or by surgery.
Symptoms of pelvic pain are mentioned as moderate to severe.
Women in the age group of 18 to 45 years
Exclusion criteria:
The presence of symptoms related to pelvic infections
GNRH agonist use in the past 3 months
Pap smear or abnormal pelvic pathology
The presence of contraindications to the use of hormonal drugs
Desire to become pregnant within the next four months
Presence of surgical indication for endometriosis in the patient
Use of hormonal drugs in the past month
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, simple randomization is done with the help of a table of random numbers.
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 Shahid Beheshti Medical University
Street address
Eerabi avenue, Taleghani hospital
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2024-08-21, 1403/05/31
Ethics committee reference number
IR.SBMU.MSP.REC.1403.292
Health conditions studied
1
Description of health condition studied
endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
endometriosis related pelvic pain
Timepoint
To assess the level of pelvic pain caused by endometriosis at the beginning of the study and 30, 90, and 180 days later
Method of measurement
verbal rating scale and visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group is treated with 2 mg of Verogest, one tablet every night for 180 days without forgetting.
Category
Treatment - Drugs
2
Description
Intervention group: The second group is treated with an oral contraceptive pill containing 0.03 micrograms of ethinyl estradiol and 2 mg of dienogest, one effective pill every night without forgetting for 180 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Aida Mazloomi
Street address
Eerabi Ave.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2570
Email
idaluxurious@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Eerabi Ave.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Email
idaluxurious@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Aida Mazloomi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eerabi Ave.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2570
Email
idaluxurious@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Aida Mazloomi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eerabi Ave.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2570
Email
idaluxurious@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Aida Mazloomi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eerabi Ave.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2570
Email
idaluxurious@gmail.com
Sharing plan
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Shared files: Participant data file, study protocol, statistical analysis map, informed consent form, clinical study report, codes used in analysis and data classification system. All data can be shared after de-identification.
When the data will become available and for how long
Access period starts 6 months after results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to use the data in therapeutic work and also to conduct further studies
From where data/document is obtainable
Applicants should visit the following email address to receive data:
idaluxurious@gmail.com
What processes are involved for a request to access data/document
Applicants should visit the following email address to receive data:
idaluxurious@gmail.com
Applicants must first provide information about their research field and the purpose for which they want these files, and after review by me, if deemed appropriate, the files will be made available to the applicant.