MedTrace Logo

Effects of Simvastatin on Uterine Leiomyoma Size

NCT03400826 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-14

No results posted yet for this study

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

Interventions

DRUG

Simvastatin 40mg

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

DRUG

Placebo 40 mg

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Mostafa Borahay, MD, PhD · Johsn Hopkins School Of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400826 on ClinicalTrials.gov