← Back to Search

HMG-CoA reductase inhibitor

Simvastatin for Uterine Fibroids

Phase 2

Recruiting

Led By Mostafa Borahay, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one fibroid of diameter > 3cm

Gender: female

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at visit 3 (6 weeks after start of study drug), and visit 4 (12 weeks after start of the study drug)

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial is testing if simvastatin, a cholesterol-lowering drug, can reduce the size of uterine fibroids in women who are planning to undergo surgery. The study will see if simvastatin helps shrink the fibroids. Simvastatin is a well-known cholesterol-lowering drug that has been extensively studied for its effects on lipid profiles and cardiovascular health.

Who is the study for?

Women aged 18-55 with uterine fibroids causing heavy bleeding and pelvic pain are eligible for this trial. They must have at least one fibroid larger than 3cm, be using contraception, and not be pregnant or breastfeeding. Exclusions include allergies to simvastatin, liver disease, other cancers, menopause status, or currently in another study.

What is being tested?

The trial is testing whether Simvastatin (40mg), a medication typically used to lower cholesterol, can reduce the size of uterine fibroids compared to a placebo. Participants will randomly receive either the drug or an inactive substance.

What are the potential side effects?

Simvastatin may cause muscle pain or weakness (myopathy), liver issues (elevated liver enzymes), digestive problems like constipation or nausea, headache, and increased risk of diabetes. It's important to monitor for any unusual symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a fibroid larger than 3cm.

Select...

I am female.

Select...

My condition involves the inner or middle layers of a wall.

Select...

I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking simvastatin or a similar medication.

Select...

I am not taking strong medications that affect liver enzymes.

Select...

I need surgery within 3 months for health or personal reasons.

Select...

I am not taking gemfibrozil, cyclosporine, danazol, certain heart medications, lomitapide, or consuming grapefruit juice.

Select...

My doctors suspect I have leiomyosarcoma.

Select...

I have unexplained gynecological symptoms.

Select...

I have been diagnosed with or am at high risk for muscle disease.

Select...

I have liver disease or my liver tests are higher than normal.

Select...

I have or had abnormal thickening of my uterus lining.

Select...

I have had or currently have cancer of the uterus, cervix, or ovaries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4 (12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4 (12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at visit 2 (start of the study drug intake), visit 3 (6 weeks after start of the study drug), visit 4 (12 weeks after start of the study drug), and follow up visit at 2 and 6 weeks post hysterectomy. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Tumor size volume pre and post study intervention

Secondary study objectives

Adherence to the recommended treatment dosing

Clinical symptom improvement as determined by the Uterine Fibroid Symptom and Health Related Quality of Life Questionnaire.

Subject retention

Other study objectives

Adverse events reporting by organ systems

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment GroupExperimental Treatment1 Intervention

The 30 participants randomized in this group will intake Simvastatin 40mg / day of orally at the same time in the evening, every day for the study duration of 12 weeks prior to undergoing hysterectomy/ myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue.

Group II: Placebo GroupPlacebo Group1 Intervention

The 30 participants randomized in this group will intake Placebo 40mg / day orally at the same time in the evening every day for the study duration of 12 weeks prior to undergoing hysterectomy/ myomectomy. The fibroid samples will be collected after the surgery to evaluate the effects of the study medication on the fibroid tissue.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Simvastatin

FDA approved

0 / 14Eligibility criteria met