Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Lipid Regulating Agents

All Drugs and Chemicals

Simvastatin

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

The 30 participants randomized in this group will intake Simvastatin 40mg / day of orally at the same time in the evening, every day for the study duration of 12 weeks prior to undergoing hysterectomy/ myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue.

The 30 participants randomized in this group will intake Placebo 40mg / day orally at the same time in the evening every day for the study duration of 12 weeks prior to undergoing hysterectomy/ myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue.

The Treatment Group subjects will orally intake encapsulated Simvastatin 40 mg tablets daily for the 12 weeks duration with water in the evening.

Simvastatin 40mg

The Placebo group will orally intake encapsulated Starch 1500, 40 mg Placebo for 12 weeks duration with water in the evening.

Placebo 40 mg

Mostafa Borahay, MD, PhD

James Segars, MD

Gayane Yenokyan, PhD

Paul Driggers, PhD

Bhuchitra Singh, MBBS,MPH,MS

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

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.

Effects of Simvastatin on Uterine Leiomyoma Size

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

Based on patient reporting and study team evaluation utilizing CTCAE v.4

Tumor size measured by ultrasound imaging comparing tumor volume using ultrasound imaging. The volume will be reported in Centimeter cubes. The largest radius of the tumor will be used to calculate the volume, this will be measured in centimeters.

The questionnaire used is the Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire. This questionnaire is an effective and validated tool for detecting differences in symptom severity and health-related quality of life among patients with uterine fibroids. The scale for this questionnaire denotes symptom severity with lowest and highest possible scores of 8 and 40 respectively. Higher scores indicate greater severity of symptoms.

Based on review of patient diaries and counting of left over medications bought back by the subject. This will be reported as an overall percentage.

Based on presence at follow up visits to the study site. This will be determined as a simple percentage of subjects that stay in the study until the last visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of Simvastatin on Uterine Leiomyoma Size	NCT03400826	Fibroid Uterus Fibroid Tumor Leiomyoma Fibromyoma Leiomyoma, Uter...	Simvastatin 40m... Placebo 40 mg	18 Years - 55 Years	Johns Hopkins University
Effects of Simvastatin on Uterine Leiomyoma Size	NCT03400826	Fibroid Uterus Fibroid Tumor Leiomyoma Fibromyoma Leiomyoma, Uter...	Simvastatin 40m... Placebo 40 mg	18 Years - 55 Years	Johns Hopkins University

Spots Global Cancer Trial Database for placebo 40 mg