Evaluation of the effectiveness of Dienogest compared to placebo in reducing dysmenorrhea in women with primary and secondary dysmenorrhea
Design
This three-phase clinical trial, with parallel groups, randomized (using the allocation randomization rule) is performed on 60 women with dysmenorrhea.
Settings and conduct
In this interventional study, 60 women suffering from primary or secondary dysmenorrhea are selected by convenience sampling method in Yas Hospital. Then, 30 women will be placed in the intervention group (Dienogest prescription) and 30 women will be placed in the control group (placebo prescription) using the random allocation method. This study is double-blind, the participants (with placebo using) and the physician who evaluates the outcome are kept blind. The physician evaluating the outcome does not know the treatment group of the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria include women aged 20 to 45 years, noticeable pain in the lower abdomen or pelvic area during menstruation, regular mensuration cycles, and normal genital system physical examination and ultrasound. Exclusion criteria: patients with abnormal serum lipid profile, and chronic diseases or chronic pelvic pain.
Intervention groups
For the Intervention group, half a milligram of dienogest (a quarter of a pill) is prescribed twice a day (every 12 hours) from the second day of menstruation and is continued for 12 weeks. For the control group, the placebo (a quarter of a pill) is prescribed twice a day (every 12 hours) from the second day of menstruation and is continued for 12 weeks.
Main outcome variables
Dysmenorrhea, premenstrual symptoms, and Dienogest side effects are measured four times every four weeks during the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150105020558N5
Registration date:2022-09-18, 1401/06/27
Registration timing:prospective
Last update:2022-09-18, 1401/06/27
Update count:0
Registration date
2022-09-18, 1401/06/27
Registrant information
Name
Mahbod Ebrahimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8882 7794
Email address
maebrahimi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Dienogest compared to placebo in reducing dysmenorrhea in women with primary and secondary dysmenorrhea
Public title
The effectiveness of Dienogest in reducing dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 45 years old
Noticeable pain (Visual Analogue Scale>=4) in the lower abdomen or pelvic area during menstruation in the last six months
With regular mensuration cycles
With normal genital system physical examination and ultrasound
Exclusion criteria:
Withdrawal to participation
Patients with adenomyosis, submucosal myoma, or endometriosis
Patients with abnormal serum lipid profile
Patients with underlying diseases or chronic pelvic pain
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 30 letters A and 30 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (Dienogest) or B (Placebo) are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind. In this study, the participants and the physician who evaluates the outcomes, are blind. The participants are blinded by using a placebo that is the same as Dienogest, and the physician evaluating the outcomes does not know the treatment group of the participants.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences, School of Medicine, Pour Sina Ave., Qods Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2022-09-03, 1401/06/12
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.430
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.6
ICD-10 code description
Dysmenorrhea, unspecified
Primary outcomes
1
Description
Dysmenorrhea
Timepoint
Four times (once before the intervention and three times after the intervention) every four weeks
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Estrogen levels
Timepoint
Before the intervention and at the end of the study.
Method of measurement
Serum Estradiol (E2) measurement
2
Description
Premenstrual symptoms
Timepoint
Four times (once before the intervention and three times after the intervention) every four weeks
Method of measurement
Menstrual Distress Questionnaire
3
Description
Dienogest side effects
Timepoint
Four times (once before the intervention and three times after the intervention) every four weeks
Method of measurement
Patient interview
Intervention groups
1
Description
Intervention group: For this group of patients, 0.5 milligrams Dienogest (one-quarter of a tablet produced by the Aburihan pharmaceutical factory named Dinovol) is prescribed twice a day (every 12 hours) from the second day of the patient's mensuration cycles and continues for 12 weeks. Dienogest is the newest generation of progesterone and the only oral progesterone. During the study period, every 4 weeks, the patient is visited regarding dysmenorrhea and drug side effects.
Category
Treatment - Drugs
2
Description
Control group: For this group of patients, one-quarter of a placebo tablet, produced by the Aburihan pharmaceutical factory, is prescribed twice a day (every 12 hours) from the second day of the patient's mensuration cycles and continues for 12 weeks. The placebo tablet is the same as Dinovol. During the study period, every 4 weeks, the patient is visited regarding dysmenorrhea and drug side effects.
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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
All data is potentially shareable after unidentified participants.
When the data will become available and for how long
After the manuscript is published.
To whom data/document is available
No limitations.
Under which criteria data/document could be used
Those who are allowed to request to receive non-identifiable personal data or other documents must have a written proposal (including the type of statistical analysis) and the ethics number. any additional analysis must perform under the corresponding author's supervision.
From where data/document is obtainable
Communicate with the corresponding author via email: maeb214@yahoo.com
What processes are involved for a request to access data/document
Any request must be sent through e-mail and accompanied by a proposal with an ethics code under the supervision of Dr. Ebrahimi.