Status:
COMPLETED
Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids
Lead Sponsor:
BioPro Medical Ltd
Conditions:
Uterine Fibroid
Vaginal Bleeding.
Eligibility:
FEMALE
30-53 years
Phase:
PHASE2
Brief 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.
Detailed Description
Uterine fibroids are benign tumors of the uterus made up of smooth muscle and the extracellular matrix proteins Collagen and Elastin. They are exceptionally common; the cumulative incidence of a diagn...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00881140
Start Date
April 1 2009
End Date
July 1 2012
Last Update
December 19 2012
Active Locations (2)
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1
Rabin Medical Center
Petah Tikva, Hasaron, Israel
2
Gynecolaoy department - Shiba Medical Center Tel Hashomer
Ramat Gan, Israel, 52621