I have 2 very large fibroids (10 cm). One is compressing the bladder against the anterior addominal wall. My symptoms are pressure and frequent urination. I am making an appt. with a specialist at Johns Hopkins Fibroid Center. My symptoms are really not that bad right now, but I'm worried they could get worse. I've read several published articles about ulipristal acetate being used to shrink fibroids. I wonder if this is even a possibility to use it for this off label use in the United States. I really would like to avoid surgery. Any feedback appreciated. I'm worried. Thanks!
Dear mirim: Interestingly the FDA approved this drug for the new Emergency Contraceptive Pill (ECP) called Ella. Unlike all of our previous ECPs which contain either synthetic estrogen and progesterone—or synthetic progesterone only—"Ella" contains a different type of medication. It is a progesterone agonist/antagonist called ulipristal acetate. This medication works both like a synthetic progesterone and like a progesterone blocking drug.
A literature search at the National Library of Medicine site yielded 16 citations on the use of ulipristal acetate for fibroids, most of these are published within the last few years. Here is one of the most rigorous studies:
N Engl J Med. 2012 Feb 2;366(5):421-32. Ulipristal acetate versus leuprolide acetate for uterine fibroids. Donnez J, Tomaszewski J, V?zquez F, Bouchard P, Lemieszczuk B, Bar? F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Collaborators (52) Source
Cliniques Universitaires Saint-Luc Catholic University of Louvain, Brussels, Belgium. email@example.com Abstract BACKGROUND:
The efficacy and side-effect profile of ulipristal acetate as compared with those of leuprolide acetate for the treatment of symptomatic uterine fibroids before surgery are unclear. METHODS:
In this double-blind noninferiority trial, we randomly assigned 307 patients with symptomatic fibroids and excessive uterine bleeding to receive 3 months of daily therapy with oral ulipristal acetate (at a dose of either 5 mg or 10 mg) or once-monthly intramuscular injections of leuprolide acetate (at a dose of 3.75 mg). The primary outcome was the proportion of patients with controlled bleeding at week 13, with a prespecified noninferiority margin of -20%. RESULTS:
Uterine bleeding was controlled in 90% of patients receiving 5 mg of ulipristal acetate, in 98% of those receiving 10 mg of ulipristal acetate, and in 89% of those receiving leuprolide acetate, for differences (as compared with leuprolide acetate) of 1.2 percentage points (95% confidence interval [CI>, -9.3 to 11. for 5 mg of ulipristal acetate and 8.8 percentage points (95% CI, 0.4 to 18.3) for 10 mg of ulipristal acetate. Median times to amenorrhea were 7 days for patients receiving 5 mg of ulipristal acetate, 5 days for those receiving 10 mg of ulipristal acetate, and 21 days for those receiving leuprolide acetate. Moderate-to-severe hot flashes were reported for 11% of patients receiving 5 mg of ulipristal acetate, for 10% of those receiving 10 mg of ulipristal acetate, and for 40% of those receiving leuprolide acetate (P<0.001 for each dose of ulipristal acetate vs. leuprolide acetate). CONCLUSIONS:
Both the 5-mg and 10-mg daily doses of ulipristal acetate were noninferior to once-monthly leuprolide acetate in controlling uterine bleeding and were significantly less likely to cause hot flashes. (Funded by PregLem; ClinicalTrials.gov number, NCT00740831.).
Mirim, I was not able to access the characteristics of the women who participated in this trial (ie size or number of fibroids required for inclusion in the study). If you are really interested in this treatment I would urge you to get the list of collaborators, see if any are in the US, and if any would be willing to do an off label treatment. It may also be that your local GYN would be willing. As you know, off-label treatments can be done, but there may be hesitation about the medical-legal aspects.
Please let us know if you do opt for this medication--especially your outcome. A 10 cm anterior fibroid has got to be very symptomatic!
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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