PROMISe Study

This study is currently recruiting participants.
Verified on June 2011 by University of California, San Francisco 

This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit. 

Here is the link:
http://clinicaltrials.gov/ct2/show/NCT01377519?term=Magnetic+Resonance-guided+Focused+Ultrasound&rank=2 

Study Start Date: June 2011
Estimated Study Completion Date: July 2012 

The study is taking place at the University of California, San Francisco.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377519

For more information on this study and to check your eligibility, pleases contact:
University of California, San Francisco 
San Francisco, California, United States, 94115
Contact: Shirley Wong 415-502-4082
Principal Investigator: Vanessa Jacoby, MD
Sub-Investigator: Fergus Coakley, MD