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IRCT20140820018866N7 IRCT 2019-06-12 Tehran University of Medical Sciences Effect of Aromatase inhibitors combination with oral contraceptive pills versus GnRH agonist on uterine myoma Effect of Aromatase inhibitors in combination with oral contraceptive pills versus GnRH agonist on the treatment of uterine myoma 2019-08-23 anticipated 42 Complete https://irct.ir/trial/36763 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The considered sample size is 42, with 21 participant in each group. Block randomization method will be designed by using "www.sealedenvelope.com". The size of blocks considered is 6. The random allocation list for patients will be solely available to the epidemiologist. To hide the random allocation process, 42 card sequences of treatments will be written accordingly, and then the cards will be placed inside sealed envelopes. A 10-digit random code will be written on each packet as the patient's identification number. When the physician announces the eligibility of a patient, the methodologist will provide the envelope. 3 Uterine Myoma. Intervention 1: Intervention group 1: Will receive one Letrozole 2.5 mg oral tablet plus one LD oral tablet per day, for a period of three months. Intervention 2: Intervention group 2: Will receive one decapeptyl 3.75 mg (made in France) IM injection every month, for three 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 The research team has not yet decided on how to publish the data.
public Dr Niloofar Sadeghizadeh
No. 162 Aَlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 niloofar.sz@gmail.com Tehran University of Medical Sciences scientific Dr. Afsaneh Tehranian
No. 162 Aَlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 afsanehtehranian@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Presence of at least one uterine myoma with a size of 2 centimeters (cm) or larger in ultrasound aged between 20 and 45 years old 20 years 45 years Female Receiving other therapeutic strategies for treatment of the myoma Ovarian cyst or neoplasm Size of largest myoma larger than 10 cm More than 5 myomas Endometrial or cervical pathology exposure to hormonal agents in last month before the trial began Hepatic, cardiovascular and Renal diseases, peptic ulcer, malignancy, and other serious medical conditions Pregnancy or lactation Indication or tendency for surgical intervention D25 Leiomyoma of uterus Treatment - Drugs Treatment - Drugs Intervention group 1: Will receive one Letrozole 2.5 mg oral tablet plus one LD oral tablet per day, for a period of three months. Intervention group 2: Will receive one decapeptyl 3.75 mg (made in France) IM injection every month, for three months. Average vaginal bleeding. Timepoint: Once before the intervention began, then 1, 2 , and 3 months after the intervention began. Method of measurement: pictorial blood assessment chart. Hemoglobin. Timepoint: Once before and once three months after the intervention began. Method of measurement: Blood Test. Pelvic Pain. Timepoint: Once before and once three months after the intervention began. Method of measurement: Visual Analog Scale (VAS). Myoma Size. Timepoint: Once before and once three months after the intervention began. Method of measurement: Ultrasound. Uterine Size. Timepoint: Once before and once three months after the intervention began. Method of measurement: Ultrasound. Number of Fibroids. Timepoint: Once before and once three months after the intervention began. Method of measurement: Ultrasound. Dysmenorrhea. Timepoint: Once before the intervention began, then 1, 2 , and 3 months after the intervention began. Method of measurement: Visual Analog Scale (VAS). Follicle Stimulating Hormone (FSH) Level. Timepoint: Once before and once three months after the intervention began. Method of measurement: Blood Test. Luteinizing hormone (LH) Level. Timepoint: Once before and once three months after the intervention began. Method of measurement: Blood Test. Bone Marrow Density (BMD). Timepoint: Once before and once three months after the intervention began. Method of measurement: Dual Energy X-ray Absorptiometry. Estradiol (E2) Hormone Level. Timepoint: Once before and once three months after the intervention began. Method of measurement: Blood Test. Progesterone Hormone Level. Timepoint: Once before and once three months after the intervention began. Method of measurement: Blood Test. Testosterone Hormone Level. Timepoint: Once before and once three months after the intervention began. Method of measurement: Blood Test. Hot-flash. Timepoint: Daily. Method of measurement: Hot Flashes Diary. Vitamin D3 Level. Timepoint: Once before and once three months after the intervention began. Method of measurement: Blood Test. Tehran University of Medical Sciences Approved 2019-01-08 Ethics committee of Tehran University of Medical Science Keshavarz Boulevard, Qods Street, Tehran University of Medical Science Tehran Tehran Iran (Islamic Republic of)