Effect of Simvastatin on Uterine Fibroids
A Double-blinded, Phase II, Randomized Control Trial to Study the Effects of Simvastatin in Patients With Uterine Leiomyoma
This study is testing if simvastatin can help reduce the size of uterine fibroids in women who have symptoms and are planning for surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03400826 on ClinicalTrials.gov |
What this trial studies
This phase II double-blinded clinical trial investigates the impact of simvastatin on the size of uterine fibroids in women who are symptomatic and scheduled for surgical management. A total of 60 participants will be enrolled, with half receiving simvastatin and the other half receiving a placebo, alongside their ongoing medical management. Participants will be monitored through ultrasound and quality of life questionnaires to assess changes in fibroid size and associated symptoms. The study aims to evaluate the feasibility, safety, and preliminary efficacy of simvastatin in reducing fibroid size before surgery.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-55 with symptomatic uterine fibroids measuring over 3 cm who are planning to undergo surgical management.
Not a fit: Patients with asymptomatic fibroids or those who do not meet the eligibility criteria, such as having a BMI over 45 kg/m2, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-surgical option for women suffering from symptomatic uterine fibroids, potentially reducing the need for surgery.
How similar studies have performed: While the use of simvastatin for this purpose is novel, other studies have explored medical management of fibroids with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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, including menstrual bleeding lasting 5 or more days or heavy bleeding per participant recall. Examples of heavy bleeding may include, but are not limited to the following: * Requires the use of double protection to manage menstrual bleeding. * Menstrual bleeding accompanied by the sensation of "gushing" or "flooding". * Saturates more than 1 tampon or sanitary pad per hour for 3 or more consecutive hours. * Regularly needs to change the tampon or sanitary pad at night or regularly soils bedclothes. * Heavy bleeding that affects work, school, or social activities. * Pelvic pain/ pressure likely caused by fibroids. * Plan for surgery (hysterectomy or myomectomy). * Normal Pap smear within the last year. * Use of contraception during study such as non-hormonal oral contraceptives, intrauterine devices (IUD)/ intrauterine systems (IUS), barrier contraceptives, abstinence or sterilization. Exclusion Criteria: * Pregnancy or lactation. * Previous or current uterine, cervical or ovarian cancer. * Current endometrial hyperplasia or history of atypical endometrial hyperplasia. Endometrial biopsy will be done during screening (if not done within last 12 months). * Suspicion of leiomyosarcoma. * Recent rapid growth of fibroids (i.e. doubling in size within 1-6 months period). * Unevaluated gynecologic abnormalities (unexplained vaginal bleeding, cervical dysplasia, or abnormal adnexal/ovarian mass). * Menopausal status. * Surgery is urgently indicated (\< 3 months) for medical or social reasons. * Hemoglobin ≤ 6 g/dL. * Currently enrolled in another investigational study. * Mental condition or other barrier preventing informed written consent. * Allergy or hypersensitivity to simvastatin. * Current use of simvastatin or other drugs of the same class. * Concomitant administration of strong CYP3A4 inhibitors including itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, and cobicistat-containing products. * Concomitant administration of gemfibrozil, cyclosporine, or danazol, verapamil, diltiazem, amiodarone, diltiazem, dronedarone, amlodipine, ranolazine, lomitapide, and grapefruit juice. * Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels.( elevation of aspartate transaminase and/or alanine transaminase \> 2 s.d. above the normal range at screening visit) * Known increased risk or diagnosis of a myopathy.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Mostafa Borahay, MD, PhD — Johsn Hopkins School Of Medicine
- Study coordinator: Mostafa Borahay, MD, PhD
- Email: mboraha1@jhmi.edu
- Phone: (410) 550-0337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.