NCT03134157

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

Evaluation the Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Royan Institute · Other Government
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	oral drug and vaginal placebo	prescription of simvastatin 40 mg orally+ vaginal placebo every day for 3 months.
DRUG	oral drug and oral placebo	prescription of simvastatin 40 mg orally+ oral placebo every day for 3 months.
DRUG	Vaginal placebo+ oral placebo	prescription of Vaginal placebo + oral placebo every day for 3 months.

Timeline

• Start date: 2016-08-01
• Primary completion: 2021-06-14
• Completion: 2021-09-14
• First posted: 2017-04-28
• Last updated: 2020-10-06

Locations

1 site across 1 country: Iran