Effect of Simvastatin in Treatment of Uterine Leiomyoma

Not Applicable

Recruiting

• Conditions: terine Fibroid.; Leiomyoma of uterus

• Registration Number: IRCT20080831001141N34
• Lead Sponsor: Royan Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

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 <3 cm and a history of 2 IVF failures.
Number of fibroids = 5
Body Mass Index >25 Kg/m2

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
terine fibroid size. Timepoint: Before and 3 months after starting the treatment. Method of measurement: Evaluation the size of uterine fibroid with ultrasound.

Secondary Outcome Measures

Name	Time	Method
terine 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.