Uterine Myoma. Leiomyoma of uterus
Conditions
Interventions
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 on
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Niloofar Sadeghizadeh
Tehran University of Medical Sciences
Outcome results
None listed