Spots Global Cancer Trial Database for Effects of Simvastatin on Uterine Leiomyoma Size

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Trial Identification

Brief Title: Effects of Simvastatin on Uterine Leiomyoma Size

Official Title: A Double-blinded, Phase II, Randomized Control Trial to Study the Effects of Simvastatin in Patients With Uterine Leiomyoma

Study ID: NCT03400826

Conditions

Interventions

Simvastatin 40mg

Placebo 40 mg

Study Description

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

Detailed 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.