Effects of Simvastatin on Uterine Leiomyoma Size

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorJohns Hopkins University

About this trial

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

Eligibility criteria

Qualifiers

Signed informed written consent.

Gender: female.

Age: 18-55 years at time of signing consent.

BMI of subjects: < 45 kg/m2.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Simvastatin 40mg
  • Placebo 40 mg

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

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

Collaborator