RecruitingPhase 2NCT03400826

Effects of Simvastatin on Uterine Leiomyoma Size

A Double-blinded, Phase II, Randomized Control Trial to Study the Effects of Simvastatin in Patients With Uterine Leiomyoma


Sponsor

Johns Hopkins University

Enrollment

60 participants

Start Date

Aug 20, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims to study the effect of simvastatin on the size of uterine fibroids.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether simvastatin — a common cholesterol-lowering medication — can reduce the size of uterine fibroids (non-cancerous growths in the uterus) and relieve symptoms like heavy menstrual bleeding in women who have symptomatic fibroids. **You may be eligible if...** - You are a woman between 18 and 55 years old - You have uterine fibroids diagnosed by ultrasound or MRI - You have at least one fibroid larger than 3 cm in diameter - Your fibroids are located inside the uterine wall or just beneath the lining (intramural or submucosal) - You have experienced heavy or prolonged menstrual bleeding in at least 3 of the last 6 cycles - Your BMI is under 45 kg per square metre - You have signed an informed consent form **You may NOT be eligible if...** - You are currently pregnant or planning to become pregnant during the study - You are post-menopausal or have had a prior fibroid treatment - You are currently taking medications that interact with simvastatin - Your fibroids are only located on the outside surface of the uterus Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSimvastatin 40mg

The Treatment Group subjects will orally intake encapsulated Simvastatin 40 mg tablets daily for the 12 weeks duration with water in the evening.

DRUGPlacebo 40 mg

The Placebo group will orally intake encapsulated Starch 1500, 40 mg Placebo for 12 weeks duration with water in the evening.


Locations(1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

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NCT03400826


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