Could a common cholesterol drug shrink uterine fibroids?

NCT ID NCT03400826

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This phase II trial tests whether simvastatin, a widely used cholesterol medication, can reduce the size of uterine fibroids and ease related symptoms. Researchers will give 60 women either simvastatin or a placebo daily for 12 weeks, measuring fibroid volume by ultrasound and tracking symptom changes with a validated questionnaire. The goal is to find a simple, drug-based alternative to surgery for fibroids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
simvastatin 40 mg daily for 12 weeks
What this could lead to
If it works, this could point toward a non-surgical treatment for uterine fibroids using a common, low-cost drug.
What could go wrong
This is a small, early-phase trial with only 60 participants. The drug may not shrink fibroids or improve symptoms, and simvastatin has known side effects like muscle pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2018

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Fibroid tumor are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21218, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.