CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 70 enrolled
Drug / intervention
Mifepristone +1 moredrug
Likely dose
Mifepristone 5 mg orally once daily for 6 monthsAI-extracted
Key inclusion· 6
  • ✓Female, ages 18 to premenopausal
  • ✓At least one fibroid ≥2.5 cm in size with total uterine volume ≥160 cc by ultrasound
  • ✓At least moderate menorrhagia or pelvic pain/pressure symptoms
  • ✓UFSS-QoL score ≥39
Key exclusion· 16
  • ✕Current or planned pregnancy during study
  • ✕Menopausal (FSH level elevated)
  • ✕Hemoglobin <9.0 g/dL
  • ✕Abnormal pap smear (untreated)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00133705
NCT00133705Phase 3Completed
CompareCT.gov

Randomized Control Trial Of Mifepristone for Fibroids

University of Rochester·interventional·Posted Aug 23, 2005·Updated Sep 25, 2023

In Brief

A Phase 3 clinical trial evaluating Mifepristone and Inert Capsule for Leiomyoma. Completed, enrolled 70 participants across 1 site.

Detailed Summary

The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeiomyoma
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 23, 2005
Enrollment StartJul 1, 2003
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 20.9 years ago

Interventions

Mifepristonedrug

Mifepristone 5mg/day by mouth for 6 months

Inert Capsuledrug

sugar pill