A Double-blinded, Phase II, Randomized Control Trial to Study the Effects of Simvastatin in Patients With Uterine Leiomyoma
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.
Arms & interventions
- DrugSimvastatin 40mg
The Treatment Group subjects will orally intake encapsulated Simvastatin 40 mg tablets daily for the 12 weeks duration with water in the evening.
- DrugPlacebo 40 mg
The Placebo group will orally intake encapsulated Starch 1500, 40 mg Placebo for 12 weeks duration with water in the evening.
Outcome measures
Primary
Change in Tumor size volume pre and post study intervention
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.
Time frame: Change from baseline to 12 weeks post intervention
Secondary
Clinical symptom improvement as determined by the Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire.
Time frame: At visit 1 (Screening), At visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4( 12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy
Adherence to the recommended treatment dosing
Time frame: At Visit 3 (6 weeks after start of study drug), and Visit 4 (12 weeks after start of the study drug)
Subject retention
Time frame: At visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4 (12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy.
Eligibility criteria
Study locations (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21218
References
- Britten J, Roura-Monllor JA, Malik M, Moran S, DeAngelis A, Driggers P, Afrin S, Borahay M, Catherino WH. Simvastatin induces degradation of the extracellular matrix in human leiomyomata: novel in vitro, in vivo, and patient level evidence of matrix metalloproteinase involvement. F S Sci. 2024 Feb;5(1):80-91. doi: 10.1016/j.xfss.2023.11.005. Epub 2023 Dec 2.(PubMed)