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Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids

Authors: Donnez J, and others

Journal: Fertility & Sterility. 2015 Feb;103:519-27

Study From: Brussels, Belgium and 12 other European medical centers

Problem:  Ulipristal, currently available in Europe and Canada, is an oral medication that blocks the action of progesterone on fibroids and stops heavy bleeding and decreases the size of fibroids. In an earlier study of this medication, it was shown to be effective for 13 weeks of treatment without worrisome side-effects.  The current study examined whether the medication was still safe if women were given 3 months of treatment followed by 2 months off the medication and then another 3 months of treatment.

Study:  451 women with symptomatic uterine fibroids and heavy bleeding were given 3 months of treatment, followed by 2 months off the medication, followed by another 3 months of treatment.

Results: About 70% of women had no bleeding while on the medication and women did resume periods (but, lighter bleeding than before any treatment) during the two months they were off of the medication.  After the second treatment, fibroids had decreased in size by about 50%. Less than 5% of patients stopped the medication due to side-effects.  Pain and quality-of-life improved for most women.

Authors’ Conclusions:  Repeated 3 month treatments with daily oral ulipristal effectively controlled bleeding and pain, reduced fibroid volume, and restored quality-of-life in women with symptomatic fibroids.

Dr. Parker’s Comments:

Ulipristal appears to be a promising medication for the treatment of the symptoms often associated with fibroids: heavy bleeding and pelvic/abdominal pressure or pain.  An earlier study found the medication was safe for 13 weeks and the current study shows it is safe and effective when given 3 months on, two months off and three months on again.

In a normal menstrual cycle, the ovaries make estrogen in the beginning of the cycle which stimulates the uterine lining cells to grow. When ovulation occurs in the middle of the cycle, the ovary starts to produce progesterone in addition to the estrogen.  Progesterone makes the lining cells stop growing and gets the cells ready for implantation of a fertilized egg.  Up to now, most medications that block the action of progesterone have been shown to cause an overgrowth of the uterine lining cells because there is no brake on the cells’ growth.  The fear has been that this overgrowth could lead to cancer (a severe overgrowth) of the uterine lining cells.   However, with the two months off medication in between the treatments, this does not appear to happen.

My sense is that this medication will be an excellent treatment option for women who are close to menopause.  Once menopause starts, the ovaries stop making estrogen and progesterone so that all bleeding stops and fibroids usually shrink.  It remains to be seen whether long treatment (many months or years) will continue to be safe, but this medication does look very promising.  This medication is not yet available in the US, but is available in Europe, Canada and many other countries.

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Disclaimer: The ideas, procedures and suggestions contained on this web site are not intended as a substitute for consulting with your physician. All matters regarding your health require medical supervision.

Fibroid Doctor William H. Parker

Dr. William H. Parker is a board-certified Fellow in the American College of Obstetricians and Gynecologists. Dr. Parker is an internationally recognized expert in fibroid surgery and research. Based in Los Angeles, California, he is considered one of the best fibroid surgeons for abdominal and laparoscopic myomectomy in the United States and abroad. He has been chosen for Best Doctors in America and Top Doctors every year beginning in the late 90's.

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