Status:
RECRUITING
Effects of Simvastatin on Uterine Leiomyoma Size
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Fibroid Uterus
Fibroid Tumor
Eligibility:
FEMALE
18-55 years
Phase:
PHASE2
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 planne...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03400826
Start Date
August 20 2018
End Date
July 31 2026
Last Update
July 14 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21218