Ulipristal Acetate for Symptomatic Uterine Fibroids and Myoma-Related Hypermenorrhea Joint Statement by the German Society for Gynecological Endocrinology and Reproductive Medicine (DGGEF) and the German Professional Association of Gynecologists (BVF)
Approximately 24 million European and more than 20 million North American women between the ages of 35 and 55 are suffering from uterine fibroids, i.e. 40% of all women in this age group are affected. The symptoms are excessive uterine bleeding, anaemia, pain and infertility. Many women find their quality of life severely compromised, and this leads to hysterectomy in many cases. So far there has been no effective and well-tolerated drug. The only approved drugs for the treatment of symptomatic uterine fibroids are GnRH agonists, but their use is relatively limited because of severe side effects due to the resulting low levels of estrogen causing hot flushes, depression, mood swings, loss of libido, vaginitis and loss of bone mineral density. As fibroid growth is dependent on progesterone, progesterone receptor modulators have proven effective in pilot studies. Two randomised double-blind studies have shown the effectiveness of the progesterone receptor modulator ulipristal acetate in the preoperative treatment of leiomyomas and the control of concomitant menorrhagia. No significant side effects have occurred under a dosage of 5 and 10 mg UPA over 3 months. A cessation of menorrhagia was observed after only 7 days, and a volume reduction of the uterine fibroids by 40% was achieved within 3 months and seemed to persist even 6 months after discontinuing the drug. A preparation with a dosage of 5 mg ulipristal acetate is available as Esmya from the spring of 2012 for the preoperative treatment of leiomyomas.