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

Royan Institute

Status and phase: Unknown; Phase 3

Conditions: Infertility

Treatments: Drug: oral drug and vaginal placebo; Drug: Vaginal placebo+ oral placebo; Drug: oral drug and oral placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03134157

Royan-Emb-029

Details and patient eligibility

About

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.

Full description

The proposal of the present study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into three groups and will be randomized to receive simvastatin 40 mg orally + vaginal placebo, simvastatin 40 mg vaginally + oral placebo and vaginal placebo + oral placebo for 3 months.

CBC, Lipid profile, kidney & Liver function tests, FBS & hormonal evaluation will be performed before and after the treatment. Ultrasound examination will be performed before and after the treatment for determining of the number, size, and site of the myoma and also size of the uterus.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Simvastatin and vaginal placebo

Experimental group

Description:

The patients with leiomyoma receive simvastatin 40 mg orally+ vaginal placebo will be given every day for 3 months.

Treatment:

Drug: oral drug and vaginal placebo

Simvastatin and oral placebo

Experimental group

Description:

The patients with leiomyoma receive simvastatin 40 mg orally+ oral placebo will be given every day for 3 months.

Treatment:

Drug: oral drug and oral placebo

Vaginal placebo+ oral placebo

Experimental group

Description:

The patients with leiomyoma receive Vaginal placebo+ oral placebo every day for 3 months.

Treatment:

Drug: Vaginal placebo+ oral placebo