A Double-blinded, Phase II, Randomized Control Trial to Study the Effects of Simvastatin in Patients With Uterine Leiomyoma
Johns Hopkins University
Summary
The study aims to study the effect of simvastatin on the size of uterine fibroids.
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 medic…
Eligibility
- Age range
- 18–55 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Signed informed written consent. * Gender: female. * Age: 18-55 years at time of signing consent. * BMI of subjects: \< 45 kg/m2. * Uterine fibroids: * Diagnosed by ultrasound (MRI will be used only if ultrasound is inconclusive). * Number: any number of fibroids. * Location: submucosal or intramural. * At least one fibroid of diameter \> 3cm. * Symptoms: one or more of the following symptoms of heavy menstrual bleeding (HMB), defined as: Experienced cyclic (22 to 35 days) abnormal uterine bleeding (heavy or prolonged) in at least 3 of the last 6 menstrual periods, inclu…
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.
Location
- Johns Hopkins HospitalBaltimore, Maryland