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IRCT20211212053372N1 IRCT 2021-12-21 Iran University of Medical Sciences Comparison of the effect of cabergoline, letrozole and triptorelin on the treatment of uterine myomas: a randomized clinical trial Comparison of the effect of cabergoline, letrozole and triptorelin on the treatment of uterine myomas: a randomized clinical trial 2022-01-23 anticipated 75 Complete https://irct.ir/trial/60616 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization type: Block randomization:blocks with size of 6 Randomization tool: www.sealedenvelope.com Random sequence concealment: Each patient's drug is placed into a matte envelope and an unique code assigned by www.sealedenvelope.com is pasted on every envelope, Blinding description: This is a single blinded study. Drug intervention is the same for the three groups in terms of shape, color or appearance of drugs. Patients as well as data analyzer are unaware about the type of groups while physician investigator is aware about the type of groups or treatment intervention. 3 Uterine myoma. Intervention 1: First intervention group will be received Letrozole tab (2.5 mg once day, orally, Femara, Novartis, Basel Switzerland) for 3 months from the first day of the menstrual cycle. Intervention 2: Second intervention group will be received cabergoline tab ( 0.5 mg once week, orally, CABERLIN, Iran Hormone, Iran) for 3 months from the first day of the menstrual cycle. Intervention 3: Third intervention group will be received triptorelin syringe (2 mg once month, intramuscular, Femara, Novartis, Basel Switzerland)) for 3 months from the first day of the menstrual cycle. 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 There is no further information
public Nooshin Modaber
Hemat Highway next to Milad Tower, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 2221 modaber.n336@gmail.com Iran University of Medical Sciences scientific Shahnaz Ahmadi
Hemat Highway next to Milad Tower, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 ahmadish@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 20-45 years old women with uterine myoma (size 3 to 8 cm) presenting bleeding and pelvic pain. 18 years 45 years Female Patients who have a hemoglobin level of 9 grams per deciliter or higher and consume iron pills. Patients over the age of 45 years. Patients with basal myoma who have received hormonal treatment in the past three months. Patients with kidney and/or liver disease. Consumers of antipsychotic drugs. Patients with a history of drug treatment or surgery for uterine myoma with severe bleeding D25.9 Leiomyoma of uterus, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group will be received Letrozole tab (2.5 mg once day, orally, Femara, Novartis, Basel Switzerland) for 3 months from the first day of the menstrual cycle. Second intervention group will be received cabergoline tab ( 0.5 mg once week, orally, CABERLIN, Iran Hormone, Iran) for 3 months from the first day of the menstrual cycle. Third intervention group will be received triptorelin syringe (2 mg once month, intramuscular, Femara, Novartis, Basel Switzerland)) for 3 months from the first day of the menstrual cycle. Uterine size. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: Sonography. Uterine bleeding amount. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: menstrual cup. Uterine myoma size. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: Sonography. Lactate Dehydrogenase (LDH). Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: Lactate Dehydrogenase (LDH) Assay Kit (Colorimetric). Serum iron. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: Serum Iron Assay Kit (Colorimetric). Hemoglobin. Timepoint: At the beginning of the study (before the intervention) and three months later. Method of measurement: Hemiglobincyanide method. Possible clinical side effects of the drug (Including hot flashes, headaches, vaginal dryness and vomiting, etc.). Timepoint: During and after 12 weeks of treatment. Method of measurement: Clinical examination. Iran University of Medical Sciences Approved 2021-02-22 Ethics committee of Iran University of Medical Sciences Hemat Highway next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)