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IRCT20230522058253N10 IRCT 2026-02-05 Hamedan University of Medical Sciences treatment outcomes of dienogest alone versus dienogest with zinc in endometriosis Comparison of treatment outcomes of dienogest alone versus dienogest with zinc in endometriosis:single blind clinical-trial 2026-02-02 anticipated 72 Complete https://irct.ir/trial/88928 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: And using the block randomization method, they will be assigned to two groups A (dienogest alone) and B (dienogest with zinc) using four-blocks. In order to use block randomization, four-blocks are used, which will have 6 blocks in the following order, and each of the blocks will be numbered and will be used for 4 patients, that is, if block number 1 is selected in the lottery, the first patient will receive treatment A, the second patient will receive treatment B, the third patient will receive treatment A, and the fourth patient will receive treatment B. The fifth patient will be selected again by lottery and randomly from one of the blocks, and the type of treatment will be assigned to the fifth to eighth patients, respectively, based on the block. In the block randomization method, it is possible that a block will be selected more than once in the lottery. In this way, two equal groups of 36 patients are placed in 18 blocks of 4, Blinding description: Due to the different types of interventions, it is not possible to blind the doctor and the patient. Only the person who ultimately evaluates the patients will be unaware of the type of treatment (single blind). 3 Women with a confirmed diagnosis of endometriosis (diagnosed by laparoscopy or imaging).. Intervention 1: Intervention group: Women with confirmed endometriosis (diagnosed by laparoscopy or imaging) will be divided into two groups. Group 1: dienogest alone (dose 2 mg daily) orally, once daily. Both groups will be followed for 6 months (at intervals of 1, 3 and 6 months). Patients will be visited by a gynecologist at monthly intervals to assess symptoms and side effects. At the end of the fourth month, they will be re-evaluated for pain score and quality of life. Intervention 2: Intervention group: Women with confirmed endometriosis (diagnosed by laparoscopy or imaging) will be divided into two groups. Group 2: dienogest 2 mg daily + zinc (dose 50 mg daily) orally, once daily. Both groups will be followed for 6 months (at intervals of 1, 3 and 6 months). Patients will be visited by a gynecologist at monthly intervals to assess symptoms and side effects. At the end of the fourth month, they will be re-evaluated for pain score and quality of life. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have no decision.
public Maryam Ahmadi
Pastaran Ave
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3828 3939 maryam-ahmadi@yahoo.com Hamedan University of Medical Sciences scientific Maryam Ahmadi
Pastaran street- fatemieh hospital
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3838 0808 nalimohamadi68@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 45 years. No severe comorbidities (such as liver or kidney disease) No use of hormone therapy in the past 3 months Diagnosis of moderate to severe endometriosis. 18 years 45 years Female Pregnancy or planning to become pregnant during the study. Inaccessibility of the patient for follow-up of treatment outcome Allergy to dienogest or zinc. Unwillingness to continue participating in the study. Treatment - Drugs Treatment - Drugs Intervention group: Women with confirmed endometriosis (diagnosed by laparoscopy or imaging) will be divided into two groups. Group 1: dienogest alone (dose 2 mg daily) orally, once daily. Both groups will be followed for 6 months (at intervals of 1, 3 and 6 months). Patients will be visited by a gynecologist at monthly intervals to assess symptoms and side effects. At the end of the fourth month, they will be re-evaluated for pain score and quality of life. Intervention group: Women with confirmed endometriosis (diagnosed by laparoscopy or imaging) will be divided into two groups. Group 2: dienogest 2 mg daily + zinc (dose 50 mg daily) orally, once daily. Both groups will be followed for 6 months (at intervals of 1, 3 and 6 months). Patients will be visited by a gynecologist at monthly intervals to assess symptoms and side effects. At the end of the fourth month, they will be re-evaluated for pain score and quality of life. Determining the average pain score of endometriosis patients in the two groups of dienogest alone and dienogest combined with zinc. Timepoint: Group 1: Dienogest alone (2 mg daily dose) orally and Group 2: Dienogest 2 mg daily dose + Zinc (50 mg daily dose) orally, once daily. Both groups will be followed for 6 months (at intervals of 1, 3 and 6 months). Patients will be visited by a gynecologist at monthly intervals to assess pain . At the end of the fourth month, they will be re-evaluated for pain score. Method of measurement: VAS pain measurement tool. Determining the average quality of life score in endometriosis patients in two groups: dienogest alone and dienogest combined with zinc. Timepoint: Group 1: Dienogest alone (2 mg daily dose) orally and Group 2: Dienogest 2 mg daily dose + Zinc (50 mg daily dose) orally, once daily. Both groups will be followed up for 6 months (at intervals of 1, 3 and 6 months). Patients will be evaluated by the researcher at monthly intervals for quality of life assessment during gynecological visits. At the end of the fourth month, they will be re-evaluated for quality of life score. Method of measurement: Endometriosis-related quality of life questionnaire. Hamedan University of Medical Sciences Approved 2025-07-11 Ethics committee of hamadan University of Medical Sciences Fatemieh hospital, Pastaran Ave. hamadan Hamadan Iran (Islamic Republic of)