Actively Recruiting

Phase 2
Age: 18Years - 55Years
FEMALE
ID03400826

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

Led by Johns Hopkins University · Updated on 2025-07-14

60

Participants Needed

1

Research Sites

N/A

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

Researchers are evaluating the effects of simvastatin on the size of uterine fibroids in women with symptomatic fibroids who are scheduled for surgical treatment such as hysterectomy or myomectomy. This phase II, double-blinded clinical trial aims to assess the feasibility, safety, and early clinical effects of simvastatin in reducing leiomyoma size. The study will enroll 60 women who will be randomly assigned to two groups: one group will take simvastatin 40 mg orally once daily in the evening for 12 weeks, while the other group will take a placebo with the same schedule. Both groups will continue their usual medical management for fibroids during the study period. After 12 weeks, participants will undergo surgery to remove fibroids, and tissue samples will be collected to evaluate the medication's effects. Participants will be monitored regularly with ultrasounds to measure fibroid size and complete quality of life questionnaires assessing symptoms. The study will track clinical symptom improvements, treatment adherence, and retention at multiple visits during the 12-week treatment and follow-up after surgery. The primary outcome is the change in tumor size volume from baseline to 12 weeks post-intervention.

CONDITIONS

Brief Title

Effects of Simvastatin on Uterine Leiomyoma Size

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

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, or MRI if ultrasound is inconclusive.
  • Any number of fibroids.
  • Fibroids located submucosal or intramural.
  • At least one fibroid with diameter greater than 3 cm.
  • Symptoms of heavy menstrual bleeding or pelvic pain/pressure likely caused by fibroids.
  • Plan to undergo surgery such as hysterectomy or myomectomy.
  • Normal Pap smear within last year.
  • Use of contraception during study including non-hormonal oral contraceptives, IUD/IUS, barrier methods, abstinence, or sterilization.
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation.
  • 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 size within 1-6 months).
  • Unevaluated gynecologic abnormalities such as unexplained vaginal bleeding or abnormal ovarian mass.
  • Menopausal status.
  • Urgent surgery needed within less than 3 months.
  • Hemoglobin less than or equal to 6 g/dL.
  • Currently enrolled in another investigational study.
  • Mental condition or barrier preventing informed consent.
  • Allergy or hypersensitivity to simvastatin.
  • Current use of simvastatin or similar drugs.
  • Use of strong CYP3A4 inhibitors or certain other interacting medications.
  • Active liver disease or elevated liver enzymes.
  • Known increased risk or diagnosis of myopathy.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 weeks

Participants take either Simvastatin 40 mg or placebo orally every evening for 12 weeks before undergoing surgery for fibroids.

Visits at start, 6 weeks, and 12 weeks of treatment (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo hysterectomy or myomectomy surgery to remove fibroids, with fibroid tissue collected for study evaluation.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 6 weeks post-surgery

Participants are monitored for recovery and symptom improvement after surgery with visits at 2 and 6 weeks post-surgery.

2 follow-up visits (in-person)

Trial Site Locations

Total: 1 location

1

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21218

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Research Team

M

Mostafa Borahay, MD, PhD

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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Published Research Related To This Trial

Simvastatin induces degradation of the extracellular matrix in human leiomyomata: novel in vitro, in vivo, and patient level evidence of matrix metalloproteinase involvement.

Joy Britten, Jaime A Roura-Monllor, Minnie Malik...

https://pubmed.ncbi.nlm.nih.gov/38043603