The Effect of Vaginal Mifepristone on Reduction of Uterine Fibroids Size and the Symptoms Associated With the Fibroids - Pilot Study (Phase IIa)
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
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Decrease of uterine fibroids volume by 25% and up.
Daniel Seidman, Prof'
Israel: Ministry of Health