Uterine Fibroid. Leiomyoma of uterus
Conditions
Interventions
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
Sponsors
Royan Institute
Eligibility
Sex/Gender
Female
Age
20 Years to 39 Years
Inclusion criteria
Inclusion criteria: 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 25 Kg/m2
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uterine fibroid size. Timepoint: Before and 3 months after starting the treatment. Method of measurement: Evaluation the size of uterine fibroid with ultrasound. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahnaz Ashrafi
Royan Institute
Outcome results
None listed