Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioPro Medical Ltd
• Treatments: Mifepristone

Criteria

Inclusion Criteria:

• Uninterested in fertility during the study.

• Premenopausal status.

• Active symptoms related to uterine fibroids.

• Subjects will be obligated to use non hormonal contraceptives during the study.

Exclusion Criteria:

• Abnormal liver and renal function

• Participants with significant increase in uterine fibroids size during a short time.

• Exclusionary health problems contraindicating mifepristone included adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect.

• Current use of steroids, anticoagulants, herbals, or botanicals with possible hormonal effects.