Effects of Simvastatin on Uterine Leiomyoma Size

NCT03400826 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: IRB001498691R01HD094380-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibroid Uterus; Fibroid Tumor; Leiomyoma; Fibromyoma; Leiomyoma, Uterine

Keywords

simvastatin; fibroids; medical management; uterine fibroids; leiomyoma

Outcome Measures

Primary Outcomes (1)

• Change in Tumor size volume pre and post study intervention

  Tumor size measured by ultrasound imaging comparing tumor volume using ultrasound imaging. The volume will be reported in Centimeter cubes. The largest radius of the tumor will be used to calculate the volume, this will be measured in centimeters.

  Change from baseline to 12 weeks post intervention

Secondary Outcomes (3)

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

  At visit 1 (Screening), 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

• Adherence to the recommended treatment dosing

  At Visit 3 (6 weeks after start of study drug), and Visit 4 (12 weeks after start of the study drug)

• Subject retention

  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.

Other Outcomes (1)

• Adverse events reporting by organ systems

  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.

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Drug: Simvastatin 40mg

Placebo Group

PLACEBO COMPARATOR

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.

Drug: Placebo 40 mg

Interventions

Simvastatin 40mg DRUG

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

Also known as: Simvastatin

Treatment Group

Placebo 40 mg DRUG

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

Also known as: Starch 1500 encapsulated

Placebo Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21218, United States

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Mostafa Borahay, MD, PhD

  Johsn Hopkins School Of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Borahay, MD, PhD

CONTACT

(410) 550-0337; mboraha1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: August 20, 2018
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)