NCT00881140

Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

The Effect of Vaginal Mifepristone on Reduction of Uterine Fibroids Size and the Symptoms Associated With the Fibroids - Pilot Study (Phase IIa)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: BioPro Medical Ltd · Industry
• Sex: Female
• Age: 30 Years – 53 Years
• Healthy volunteers: Not accepted

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 diagnosis of fibroids in women aged 25 to 45 is approximately 30 percent. Uterine fibroids can cause abnormal uterine bleeding, dysmenorrhea, lower back pain and non-cyclic pelvic pain. They also can contribute to symptoms related to an enlarging pelvic mass (e.g., urinary frequency or constipation). Uterine fibroids are also associated with an increased risk of complications of pregnancy, and with infertility, although it is unclear whether this association is causative. Symptoms associated with uterine fibroids can have a significant impact on quality of life, with scores on standard measures that are comparable to those for other major chronic diseases

Conditions

• Uterine Fibroid
• Vaginal Bleeding.

Interventions

Type	Name	Description
DRUG	mifepristone vaginal tablets	Daily use of 10 mg administrated per vagina for 3 months

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2009-04-15
• Last updated: 2012-12-19

Locations

2 sites across 1 country: Israel