Effects of Simvastatin on Uterine Leiomyoma Size

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03400826
Phase
PHASE2
Status
Recruiting
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Conditions

  • Fibroid Tumor
  • Fibroid Uterus
  • Fibromyoma
  • Leiomyoma
  • Leiomyoma, Uterine

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

Start date
Aug 20, 2018
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    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.
  • Placebo Comparator: Placebo Group
    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.

Primary Outcome Measure

Change in Tumor size volume pre and post study intervention [ Time Frame: Change from baseline to 12 weeks post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21218
Mostafa Borahay, MD, PhD
[email protected]
410-550-0337
James Segars, MD (SUB_INVESTIGATOR)
Gayane Yenokyan, PhD (SUB_INVESTIGATOR)
Paul Driggers, PhD (SUB_INVESTIGATOR)
Bhuchitra Singh, MBBS,MPH,MS (SUB_INVESTIGATOR)

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