The Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Women

• Status: Recruiting
• Trial end date: 2021-09-14
• Target enrollment: 0
• Participant gender: Female

Summary

Uterine leiomyomas with an estimated incidence of 50%-80% are the most common tumors of female reproductive system. Statins as a HMG-CoA reductase inhibitors inhibit the mevalonate pathway of cholesterol synthesis, thus have been known as a group of drugs used for treatment of hypercholesterolemia. Statins inhibit proliferation of several cell types including vascular smooth muscle, hepatocytes and other cell types. Leiomyomas are benign uterine tumors characterized by smooth muscle proliferation and excessive deposition of extracellular matrix. In the present study we aim to evaluate the effect of simvastatin on uterine leiomyoma development and growth.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royan Institute
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Age between 20-40 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

• BMI>25 Kg/m2

Exclusion Criteria:

• Pregnancy

• Hormonal contraception or any hormonal therapy received in the last 3 months

• Alcohol consumption

• Allergic to simvastatin

• Suspicion or diagnosis of cancer

• Signs or symptoms of mental illness, hepatic dysfunction, myopathic syndromes, diabetes mellitus, renal disease, Cardiovascular disease, hypothyroidism, hypotension, neuropathy, lupus and cataract

• Hb ≤ 7

• Taking antifungal medications, Lipid-Lowering medications (gemfibrozil, clofibrate), warfarin, danazol and erythromycin in the last one month.

• Severe male factor

• Severe endometriosis

• Diminished ovarian reserve