NCT03400826

Effects of Simvastatin on Uterine Leiomyoma Size

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study is a phase II double blinded clinical trial to determine feasibility, safety and preliminary clinical efficacy of simvastatin to reduce leiomyoma size. Women with symptomatic fibroids planned to undergo surgical management for fibroids such as hysterectomy or myomectomy will be screened for participation. The eligible women will undergo pre-study evaluation to ascertain study eligibility.The study will enroll 60 participants in total, half will receive simvastatin and the other half will receive a placebo. The study drug and placebo will be an add on to the participants ongoing medical management of fibroids until surgery. The participants will be monitored at intervals for the effect of the drug on fibroid size and symptoms using ultrasound and quality of life questionnaires.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-20
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2018-01-17
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study