drugset / Trial / NCT01786226

Mifepristone to Treat Uterine Fibroids

NCT01786226

Phase 2/3 Terminated 220 enrolled Mediterranea Medica S. L.
RandomizedParallel-groupOpen-labelTreatment

Summary

Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period. The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.

Timeline

Start
2010-03
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Mifepristone Small molecule 2.5 mg Oral
Subject Mifepristone Small molecule 5 mg Oral