A randomized, placebo-controlled, dose-ranging trial comparing fulvestrant with goserelin in premenopausal patients with uterine fibroids awaiting hysterectomy.
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.
Donnez
Jacques
J
Catholic University of Louvain, Brussels, Belgium. donnez@gyne.ucl.ac.be
Hervais Vivancos
Blas
B
Kudela
Milan
M
Audebert
Alain
A
Jadoul
Pascale
P
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
D004965:Estrogen Antagonists; D020847:Estrogen Receptor Modulators; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D017273:Goserelin; D000077267:Fulvestrant; D004958:Estradiol