Effects of Simvastatin on Uterine Leiomyoma Size

Status Recruiting

Clinical Trial Summary

The study aims to study the effect of simvastatin on the size of uterine fibroids.

Clinical Trial Description

The study is a phase II double blinded clinical trial to determine feasibility, safety and preliminary clinical efficacy of simvastatin to reduce leiomyoma size. Women with symptomatic fibroids planned to undergo surgical management for fibroids such as hysterectomy or myomectomy will be screened for participation. The eligible women will undergo pre-study evaluation to ascertain study eligibility.The study will enroll 60 participants in total, half will receive simvastatin and the other half will receive a placebo. The study drug and placebo will be an add on to the participants ongoing medical management of fibroids until surgery. The participants will be monitored at intervals for the effect of the drug on fibroid size and symptoms using ultrasound and quality of life questionnaires. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03400826
Study type	Interventional
Source	Johns Hopkins University
Contact	Mostafa Borahay, MD, PhD
Phone	(410) 550-0337
Email	mboraha1@jhmi.edu
Status	Recruiting
Phase	Phase 2
Start date	August 20, 2018
Completion date	December 1, 2024

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