Ulipristal Acetate versus Leuprolide Acetate for Uterine Fibroids

• Published in: The New England journal of medicine Vol. 366; no. 5; pp. 421 - 432
• Main Authors: Donnez, Jacques, Tomaszewski, Janusz, Vázquez, Francisco, Bouchard, Philippe, Lemieszczuk, Boguslav, Baró, Francesco, Nouri, Kazem, Selvaggi, Luigi, Sodowski, Krzysztof, Bestel, Elke, Terrill, Paul, Osterloh, Ian, Loumaye, Ernest
• Format: Journal Article
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 02.02.2012
• Subjects: Acetic acid; Administration, Oral; Adult; Amenorrhea; Biological and medical sciences; Bleeding; Double-Blind Method; Endometrium - drug effects; Endometrium - pathology; Female; Female genital diseases; Fibroids; General aspects; Gynecology. Andrology. Obstetrics; Humans; Injections, Intramuscular; Intention to Treat Analysis; Leiomyoma - complications; Leiomyoma - drug therapy; Leiomyoma - surgery; Leuprolide - adverse effects; Leuprolide - therapeutic use; Medical sciences; Menorrhagia - drug therapy; Menorrhagia - etiology; Middle Aged; Norpregnadienes - administration & dosage; Norpregnadienes - adverse effects; Norpregnadienes - therapeutic use; Patients; Surgery; Tumors; Uterine Neoplasms - complications; Uterine Neoplasms - drug therapy; Uterine Neoplasms - surgery; Uterus; Women; Young Adult; Antineoplastic agent; Leuprorelin; Peptides; Gonadotropin RH; Nonapeptide; Acetate; Progesterone receptor; Female genital diseases; Hypothalamic hormone; Medicine; Analog; Uterine diseases; Uterine leiomyoma; Contraceptive; Benign neoplasm; Agonist antagonist; Hormone releasing factor; Ulipristal; Comparative study
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMoa1103180

In this trial comparing oral ulipristal acetate (5 mg or 10 mg daily) with once-monthly leuprolide acetate in women with symptomatic uterine fibroids before planned surgery, both doses of ulipristal acetate were noninferior to leuprolide acetate in controlling uterine bleeding. Uterine leiomyomas, or fibroids, are the most common benign uterine tumors in women of reproductive age. In addition to anemia caused by heavy bleeding, fibroids can cause pelvic pain, pressure, dysmenorrhea, reduced quality of life, and infertility. Current management strategies consist mainly of surgical or radiologic interventions; options for medical therapy are limited. 1 – 4 The use of oral progestin has not been extensively investigated, but small studies report breakthrough bleeding 5 and possible promotion of myoma growth. 6 The use of a progestin-releasing intrauterine device controls menorrhagia in some patients, but trials have generally excluded patients with uteri distorted by submucosal myomas. . . .