A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata

• Published in: Fertility and sterility Vol. 87; no. 6; pp. 1399 - 1412
• Main Authors: Chwalisz, Kristof, Larsen, Lois, Mattia-Goldberg, Cynthia, Edmonds, Anthony, Elger, Walter, Winkel, Craig A.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.06.2007; Elsevier Science
• Subjects: Adolescent; Adult; Amenorrhea; asoprisnil (J867); Biological and medical sciences; Double-Blind Method; endometrium; Estrenes - therapeutic use; Estrenes - toxicity; Female; Female genital diseases; Gynecology. Andrology. Obstetrics; Humans; Internal Medicine; leiomyoma; Leiomyoma - drug therapy; Medical sciences; menorrhagia; Middle Aged; Non tumoral diseases; Obstetrics and Gynecology; Oximes - therapeutic use; Oximes - toxicity; Oxytocics - therapeutic use; Patient Selection; pelvic pressure; Placebos; progesterone receptor; Receptors, Progesterone - drug effects; Receptors, Progesterone - physiology; selective progesterone receptor modulators (SPRMs); Tumors; Uterine Hemorrhage - epidemiology; Uterine Neoplasms - drug therapy; selective progesterone receptor modulators (SPRMs); pelvic pressure; menorrhagia; Amenorrhea; endometrium; asoprisnil (J867); progesterone receptor; leiomyoma; Andrology; Progesterone receptor; Hemorrhage; Menorrhagia; Pelvic cavity; Fertility; Female genital system; Uterine diseases; Adult; Female; Benign neoplasm; Woman; Endometrium; Human; Menstruation disorders; Modulator; Gynecology; Pressure; Asoprisnil; Female genital diseases; Randomised controlled trial; Uterine leiomyoma; Hormonal receptor
• ISSN: 0015-0282; 1556-5653; 1556-5653
• DOI: 10.1016/j.fertnstert.2006.11.094

To determine efficacy and safety of asoprisnil in patients with leiomyomata. Phase 2, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-group study. Twenty-eight sites in the United States and 1 in Canada. One hundred twenty-nine women with leiomyomata. Asoprisnil (5, 10, or 25 mg) or placebo orally daily for 12 weeks. Uterine bleeding changes by using daily bleeding diaries, hemoglobin concentrations, dominant leiomyoma and uterus volume measured sonographically, patient-reported symptoms related to bloating and pelvic pressure, endometrial thickness and morphology, hormonal parameters, and standard safety measures. Asoprisnil suppressed uterine bleeding in 28%, 64%, and 83% of subjects at 5, 10, and 25 mg, respectively, and reduced leiomyoma and uterine volumes. Median percentage decrease from baseline in leiomyoma volume was statistically significant at 25 mg compared with placebo after 4 and 8 weeks of treatment; by week 12, leiomyoma volume was reduced by 36%. There was a significant reduction in bloating with the two highest doses and in pelvic pressure with 25 mg by week 12. Asoprisnil was associated with follicular-phase estrogen concentration and minimal hypoestrogenic symptoms. After 12-week treatment, asoprisnil controlled uterine bleeding while reducing leiomyoma volume and the associated pressure symptoms. Asoprisnil was well tolerated.