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IRCT20150105020558N5 IRCT 2022-09-18 Tehran University of Medical Sciences The effectiveness of Dienogest in reducing dysmenorrhea Evaluation of the effectiveness of Dienogest compared to placebo in reducing dysmenorrhea in women with primary and secondary dysmenorrhea 2022-10-23 anticipated 60 Complete https://irct.ir/trial/65784 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Dysmenorrhea. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participants. When: After the manuscript is published. To whom: No limitations. Conditions: 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. Where to obtain: Communicate with the corresponding author via email: maeb214@yahoo.com How to obtain: Any request must be sent through e-mail and accompanied by a proposal with an ethics code under the supervision of Dr. Ebrahimi. Comments:
public Mahbod Ebrahimi
Yas hospital, Next to Sarv St., North Nejatollahi St., Karimkhan Ave.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 8882 7794 maebrahimi@tums.ac.ir Tehran University of Medical Sciences scientific Mahbod Ebrahimi
Yas Hospital, Ostad Nejatolahi Ave., Karimkhan Blvd.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 8882 7794 maeb214@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 20 years 45 years Female Withdrawal to participation Patients with adenomyosis, submucosal myoma, or endometriosis Patients with abnormal serum lipid profile Patients with underlying diseases or chronic pelvic pain N94.6 Dysmenorrhea, unspecified Treatment - Drugs Placebo 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. 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. Dysmenorrhea. Timepoint: Four times (once before the intervention and three times after the intervention) every four weeks. Method of measurement: Visual Analogue Scale. Estrogen levels. Timepoint: Before the intervention and at the end of the study. Method of measurement: Serum Estradiol (E2) measurement. Premenstrual symptoms. Timepoint: Four times (once before the intervention and three times after the intervention) every four weeks. Method of measurement: Menstrual Distress Questionnaire. Dienogest side effects. Timepoint: Four times (once before the intervention and three times after the intervention) every four weeks. Method of measurement: Patient interview. Tehran University of Medical Sciences Approved 2022-09-03 Ethical Committee of Tehran University of Medical Sciences Ethics committee of Tehran University of Medical Sciences, School of Medicine, Pour Sina Ave., Qods Blvd. Tehran Tehran Iran (Islamic Republic of)