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IRCT20080831001141N34 IRCT 2021-01-01 Royan Institute Effect of Simvastatin in Treatment of Uterine Leiomyoma Comparison of the Effectiveness of Simvastatin on Uterine Leiomyoma Development in Infertile Women 2016-08-01 anticipated 60 Complete https://irct.ir/trial/53255 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: CBC, Lipid profile, kidney & Liver function tests, FBS & hormonal evaluation will be performed before and after the treatment. Ultrasound examination will be performed before and after the treatment for determining of the number, size, and site of the myoma and also size of the uterus. Pictorial Blood Loss Assessment Chart (PBLAC) and Visual Analogue Scale (VAS) will be filled before and after the treatment, Randomization description: A randomization list was provided by statistic using randomization website (block randomization with block size of 6) and allocation was performed by a third party not directly connected with the trial, Blinding description: As soon as the patient is entered into the study, the treatment code is determined from the randomly generated sequence and a unique identification code is assigned to the patient. Random codes are stored in the main project management unit of the study and are inqueried through the clinical caregiver and the relevant intervention will be applied to the new patient. For this purpose, after determining the patient eligibility, the clinical caregiver, inquiries from the project management unit and announces the patient information and receives the patient's assigned identification and treatment code. Therefore, the clinical caregiver will not be aware of the allocative treatment until the patient is admitted. The drug Medicine packages are given to the clinical caregiver by the code they are registered with. All placebo tablets are provided by Hakim Pharmaceutical Company (Tehran, Iran), approved by the Iranian Food and Drug Administration. The appearance of placebo tablets is in color, shape and size quite similar to simvastatin tablets, which cannot be detected by patients, clinical care giver and researcher. N/A Uterine Fibroid. Intervention 1: Intervention group1: The patients with uterine fibroid will receive simvastatin 40mg orally+ vaginal placebo every day for 3 months. Intervention 2: Intervention group 2: The patients with uterine fibroid will receive simvastatin 40mg vaginally + oral placebo every day for 3 months. Intervention 3: Control group: The patients with uterine fibroid will receive Vaginal placebo+ oral placebo every day for 3 months. 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 more information
public Mahnaz Ashrafi
Number 12, East Hafez Avenue, Bani Hashem Street, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1665659911 +98 21 2356 2645 ashrafim@royaninstitute.org Royan Institute scientific Mahnaz Ashrafi
Number 12, East Hafez Avenue, Bani Hashem Street, Resalat Highway
Tehran Iran (Islamic Republic of) 1665659911 +98 21 2356 2645 ashrafim@royaninstitute.org Royan Institute Iran (Islamic Republic of) Age between 20-39 years Intramural Fibroids confirmed by ultrasound Presence of at least one fibroid with size >4 cm or two fibroids with size >3 cm detected by pelvic ultrasound. Presence of at least 3 fibroids with size <3 cm and a history of 2 IVF failures. Number of fibroids ≤ 5 Body Mass Index >25 Kg/m2 20 years 39 years Female Severe male factor Severe endometriosis Diminished ovarian reserve Breastfeeding Pregnancy Alcohol consumption Allergic to simvastatin Signs or symptoms of Muscle aches, muscle weakness, myopathic syndrome, mental illness, hepatic dysfunctions, renal disease, Cardiovascular disease, hypotension ,diabetes mellitus, hypothyroidism, neuropathy, lupus, cataract and cancer Transaminase abnormalities Hb ≤ 7 Taking antifungal medications, Lipid-Lowering medications (gemfibrozil, clofibrate and…), warfarin, danazol and erythromycin in the last one month D25 Leiomyoma of uterus Treatment - Drugs Treatment - Drugs Placebo Intervention group1: The patients with uterine fibroid will receive simvastatin 40mg orally+ vaginal placebo every day for 3 months. Intervention group 2: The patients with uterine fibroid will receive simvastatin 40mg vaginally + oral placebo every day for 3 months. Control group: The patients with uterine fibroid will receive Vaginal placebo+ oral placebo every day for 3 months. Uterine fibroid size. Timepoint: Before and 3 months after starting the treatment. Method of measurement: Evaluation the size of uterine fibroid with ultrasound. Uterine size. Timepoint: Before and 3 months after starting the treatment. Method of measurement: Evaluation the uterine size with ultrasound. Menstrual bleeding. Timepoint: Before and 3 months after starting the treatment. Method of measurement: Validated pictorial blood loss assessment chart. Dysmenorrhea. Timepoint: Before and 3 months after starting the treatment. Method of measurement: Visual analog scale. Royan Institute Approved 2015-12-08 Ethics committee of Royan Institute Number 12, East Hafez Avenue, Bani Hashem Street, Resalat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)