NCT03400826 Effects of Simvastatin on Uterine Leiomyoma Size
| NCT ID | NCT03400826 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Johns Hopkins University |
| Condition | Fibroid Uterus |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2018-08-20 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2018-08-20 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to study the effect of simvastatin on the size of uterine fibroids.
Eligibility 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.
Contact & Investigator
Mostafa Borahay, MD, PhD
PRINCIPAL INVESTIGATOR
Johsn Hopkins School Of Medicine
Frequently Asked Questions
Who can join the NCT03400826 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Fibroid Uterus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03400826 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03400826 currently recruiting?
Yes, NCT03400826 is actively recruiting participants. Contact the research team at mboraha1@jhmi.edu for enrollment information.
Where is the NCT03400826 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03400826 clinical trial?
NCT03400826 is sponsored by Johns Hopkins University. The principal investigator is Mostafa Borahay, MD, PhD at Johsn Hopkins School Of Medicine. The trial plans to enroll 60 participants.