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IRCT20240109060656N8 IRCT 2026-11-04 Shiraz University of Medical Sciences Comparison of the effectiveness of valproic acid and dienogest in reducing endometriosis symptoms Comparison of the effectiveness of valproic acid and dienogest in reducing endometriosis symptoms in patients with endometriosis 2026-11-22 anticipated 120 Pending https://irct.ir/trial/94445 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using the "Random Allocation" software, employing a permuted-block randomization method. Specifically, various blocks of four (such as ABBA, BABA, ABAB, BBAA, AABB, and BABA) will be generated; one of these blocks will be randomly selected, and patients will be assigned to either Group A or Group B based on the sequence specified within the chosen block, Blinding description: The study will be conducted as a triple-blind trial. In this study, patients will receive medications in packages coded as 'A' or 'B' and will remain unaware of the specific treatment they are receiving. The researcher will also be blinded to the treatment administered; they will provide the medication to patients in packages prepared by a collaborating pharmacist, with only the codes 'A' or 'B' marked on the packaging. Finally, the radiologist responsible for evaluating the findings from the patients' transvaginal ultrasound or pelvic MRI will also be unaware of the treatment the patients received. 1-2 Endometriosis. Intervention 1: Intervention group: Group A will receive one 2 mg dienogest tablet daily—in the morning and evening—for 6 consecutive months. Intervention 2: Intervention group: Group B will receive two 500 mg valproic acid tablets daily (in the morning and evening) for 6 consecutive months. No - There is not a plan to make this available Justification or reason for not sharing IPD is Given that the Vice-Chancellery for Research at Shiraz University of Medical Sciences is the funding body for this research project, any dissemination of information or findings related to the project must be carried out with the consent of the Vice-Chancellery.
public Shamim Shahab
Shiraz, Zand Street, Imam Hossein Square, Shiraz Faculty of Medicine
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3233 5849 neydavodi41@gmail.com Shiraz University of Medical Sciences scientific Shamim Shahab
Shiraz, Zand Street, Imam Hossein Square, Shiraz Faculty of Medicine
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3233 5849 neydavodi41@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Women with a definitive diagnosis of endometriosis They must not have received any pharmacological treatment for endometriosis prior to the start of the study. Absence of similar pharmacological treatment (dienogest or valproic acid) over the past three months No history of known allergy or hypersensitivity to medications 18 years 45 years Female Pregnancy or the intention to become pregnant during the six-month treatment period Presence of coagulation disorders or prior thrombosis N80 Endometriosis Treatment - Drugs Treatment - Drugs Intervention group: Group A will receive one 2 mg dienogest tablet daily—in the morning and evening—for 6 consecutive months. Intervention group: Group B will receive two 500 mg valproic acid tablets daily (in the morning and evening) for 6 consecutive months. Severity of pelvic pain associated with endometriosis. Timepoint: Measurements will be taken at baseline, and at 3 and 6 months after the start of treatment. Method of measurement: Pain intensity will be measured using the Visual Analogue Scale (VAS). Quality of Life in Patients with Endometriosis. Timepoint: 6 months after starting treatment. Method of measurement: Quality of Life Questionnaire for Patients with Endometriosis (EHP-30). Shiraz University of Medical Sciences Approved 2026-06-20 Specialized Committee on Ethics in Biomedical Research Shiraz, Zand Street, Imam Hossein Square, Shiraz Faculty of Medicine Shiraz Fars Iran (Islamic Republic of)