Actively Recruiting
Effects of Simvastatin on Uterine Leiomyoma Size
Led by Johns Hopkins University · Updated on 2025-07-14
60
Participants Needed
1
Research Sites
414 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study aims to study the effect of simvastatin on the size of uterine fibroids.
CONDITIONS
Official Title
Effects of Simvastatin on Uterine Leiomyoma Size
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed written consent.
- Female gender.
- Age between 18 and 55 years at time of consent.
- Body mass index (BMI) less than 45 kg/m2.
- Diagnosed uterine fibroids by ultrasound (MRI if ultrasound inconclusive).
- Any number of fibroids.
- Fibroids located submucosal or intramural.
- At least one fibroid with diameter greater than 3 cm.
- Symptoms including heavy menstrual bleeding (HMB) in at least 3 of the last 6 menstrual periods, characterized by prolonged or heavy bleeding.
- Pelvic pain or pressure likely caused by fibroids.
- Planned surgery for fibroids (hysterectomy or myomectomy).
- Normal Pap smear within the last year.
- Use of contraception during the study such as non-hormonal oral contraceptives, intrauterine devices/systems, barrier methods, abstinence, or sterilization.
You will not qualify if you...
- Pregnancy or breastfeeding.
- Previous or current uterine, cervical, or ovarian cancer.
- Current endometrial hyperplasia or history of atypical endometrial hyperplasia.
- Suspicion of leiomyosarcoma.
- Recent rapid fibroid growth (doubling in size within 1-6 months).
- Unevaluated gynecologic abnormalities such as unexplained vaginal bleeding, cervical dysplasia, or abnormal ovarian mass.
- Menopausal status.
- Surgery urgently needed within less than 3 months for medical or social reasons.
- Hemoglobin level less than or equal to 6 g/dL.
- Currently enrolled in another investigational study.
- Mental condition or other barriers preventing informed consent.
- Allergy or hypersensitivity to simvastatin.
- Current use of simvastatin or similar drugs.
- Use of strong CYP3A4 inhibitors or certain interacting medications.
- Active liver disease with elevated liver enzymes.
- Known increased risk or diagnosis of muscle disease (myopathy).
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21218
Actively Recruiting
Research Team
M
Mostafa Borahay, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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