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NCT03400826

Effects of Simvastatin on Uterine Leiomyoma Size

Active, Not Recruiting
PHASE2Ages 18–55InterventionalTreatment
Johns Hopkins University
~60 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Simvastatin 40mgPlacebo 40 mg

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Tumor size volume pre and post study intervention
Measured over Change from baseline to 12 weeks post intervention

Conditions

Fibroid Uterus
Fibroid Tumor
Leiomyoma
Fibromyoma
Leiomyoma, Uterine

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Uterine Corpus Leiomyoma

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Johns Hopkins Hospital

    Baltimore, Marylandno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mostafa Borahay, MD, PhD · PRINCIPAL_INVESTIGATOR · Johsn Hopkins School Of Medicine

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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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.

What this trial measures

  • Change in Tumor size volume pre and post study interventionChange from baseline to 12 weeks post 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.