title: A randomized, placebo-controlled, dose-ranging trial comparing fulvestrant with goserelin in premenopausal patients with uterine fibroids awaiting hysterectomy.
abstract: OBJECTIVE
  To compare the use of a new antiestrogen fulvestrant with goserelin in reducing uterine fibroid growth before hysterectomy.
  
  
  METHODS
  An international, multicenter, randomized, placebo-controlled study.
  
  
  METHODS
  Departments of obstetrics and gynecology.
  
  
  METHODS
  Premenopausal women (n = 307) diagnosed with uterine fibroids requiring hysterectomy.
  
  
  METHODS
  Over a 12-week period, patients received fulvestrant (50 mg, 125 mg, or 250 mg) as an i.m. injection, goserelin (3.6 mg) as a s.c. injection, or an injection-matched placebo once every 4 weeks. Patients underwent a hysterectomy at week 13.
  
  
  METHODS
  Efficacy endpoints included changes in fibroid growth, endometrial thickness, and uterine volume. The excretion of urinary markers of bone resorption was also examined.
  
  
  RESULTS
  Goserelin significantly reduced fibroid growth and endometrial thickness compared with placebos. Fulvestrant did not significantly alter fibroid volume or endometrial thickness or change endpoints such as endometrial histology or vaginal bleeding. Fulvestrant was associated with fewer postmenopause-related adverse events than goserelin. Goserelin, but not fulvestrant, significantly increased markers of bone resorption.
  
  
  CONCLUSIONS
  At doses equivalent to those used for the treatment of breast cancer in postmenopausal women, fulvestrant did not significantly inhibit fibroid growth and, of particular note, did not lead to bone resorption.
authors.affiliation: Catholic University of Louvain, Brussels, Belgium. donnez@gyne.ucl.ac.be
authors.forename: Jacques
authors.initials: J
authors.lastname: Donnez
authors.forename: Blas
authors.initials: B
authors.lastname: Hervais Vivancos
authors.forename: Milan
authors.initials: M
authors.lastname: Kudela
authors.forename: Alain
authors.initials: A
authors.lastname: Audebert
authors.forename: Pascale
authors.initials: P
authors.lastname: Jadoul
mesh_terms: D000328:Adult; D001706:Biopsy; D001862:Bone Resorption / Q000139:chemically induced; D004717:Endometrium / Q000473:pathology; D004958:Estradiol / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D004965:Estrogen Antagonists / Q000627:therapeutic use*; D020847:Estrogen Receptor Modulators / Q000627:therapeutic use*; D005260:Female; D000077267:Fulvestrant; D017273:Goserelin / Q000627:therapeutic use*; D006801:Humans; D007044:Hysterectomy; D007889:Leiomyoma / Q000188:drug therapy* / Q000601:surgery; D008875:Middle Aged; D017697:Premenopause; D011960:Receptors, Estrogen / Q000032:analysis; D011980:Receptors, Progesterone / Q000032:analysis; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000601:surgery
chemical_list: D004965:Estrogen Antagonists; D020847:Estrogen Receptor Modulators; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D017273:Goserelin; D000077267:Fulvestrant; D004958:Estradiol