title: A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata.
abstract: OBJECTIVE
  To determine efficacy and safety of asoprisnil in patients with leiomyomata.
  
  
  METHODS
  Phase 2, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-group study.
  
  
  METHODS
  Twenty-eight sites in the United States and 1 in Canada.
  
  
  METHODS
  One hundred twenty-nine women with leiomyomata.
  
  
  METHODS
  Asoprisnil (5, 10, or 25 mg) or placebo orally daily for 12 weeks.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  After 12-week treatment, asoprisnil controlled uterine bleeding while reducing leiomyoma volume and the associated pressure symptoms. Asoprisnil was well tolerated.
authors.affiliation: TAP Pharmaceutical Products Inc., Lake Forest, Illinois 60045, USA. kristof.chwalisz@tap.com
authors.forename: Kristof
authors.initials: K
authors.lastname: Chwalisz
authors.forename: Lois
authors.initials: L
authors.lastname: Larsen
authors.forename: Cynthia
authors.initials: C
authors.lastname: Mattia-Goldberg
authors.forename: Anthony
authors.initials: A
authors.lastname: Edmonds
authors.forename: Walter
authors.initials: W
authors.lastname: Elger
authors.forename: Craig A
authors.initials: CA
authors.lastname: Winkel
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004963:Estrenes / Q000627:therapeutic use* / Q000633:toxicity; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000188:drug therapy*; D008875:Middle Aged; D010091:Oximes / Q000627:therapeutic use* / Q000633:toxicity; D010120:Oxytocics / Q000627:therapeutic use*; D018579:Patient Selection; D010919:Placebos; D011980:Receptors, Progesterone / Q000187:drug effects / Q000502:physiology*; D014592:Uterine Hemorrhage / Q000453:epidemiology; D014594:Uterine Neoplasms / Q000188:drug therapy*
chemical_list: D004963:Estrenes; D010091:Oximes; D010120:Oxytocics; D010919:Placebos; D011980:Receptors, Progesterone; C488516:asoprisnil