Effects of raloxifene treatment on uterine leiomyomas in postmenopausal women.
OBJECTIVE
To evaluate the effects of raloxifene administration on uterine and uterine leiomyoma sizes in postmenopausal women.


METHODS
Prospective randomized, double-blind, placebo-controlled clinical trial.


METHODS
Department of Gynecology, Obstetrics, and Pathophysiology of Human Reproduction, University of Naples "Federico II", Italy.


METHODS
Seventy spontaneous postmenopausal women affected by uterine leiomyomas.


METHODS
Twelve cycles (of 28 days each) of treatment with raloxifene (60 mg daily per os) or placebo.


METHODS
At entry and at every 3 cycles, uterine and uterine leiomyoma dimensions were measured by means of transvaginal ultrasound. The difference between uterine and leiomyoma volumes (Delta size) was calculated in all subjects. The characteristics of uterine bleeding and the side effects of the treatments were assessed using a daily diary.


RESULTS
After 6, 9, and 12 cycles of therapy, in subjects treated with raloxifene, the mean uterine and uterine leiomyoma size were significantly decreased, and the mean Delta size significantly increased in comparison with basal values and the placebo group. No significant differences in uterine bleeding were detected between the two groups.


CONCLUSIONS
In postmenopausal women raloxifene appears to act selectively on uterine leiomyomas, reducing their size.
Palomba
S
S
Department of Obstetrics and Gynecology, University of Naples "Federico II", Naples, Italy. stefanopalomba@tin.it
Sammartino
A
A
Di Carlo
C
C
Affinito
P
P
Zullo
F
F
Nappi
C
C
D004311:Double-Blind Method; D004965:Estrogen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000000981:diagnostic imaging / Q000188:drug therapy*; D008875:Middle Aged; D017698:Postmenopause; D020849:Raloxifene Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014463:Ultrasonography; D014594:Uterine Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy*; D014599:Uterus / Q000000981:diagnostic imaging
D004965:Estrogen Antagonists; D020849:Raloxifene Hydrochloride