Influence of raloxifene on the efficacy of an estradiol-releasing ring for treating vaginal atrophy in postmenopausal women.
OBJECTIVE
To determine the potential interaction of oral raloxifene 60 mg/day on the efficacy of a low-dose, estradiol-releasing vaginal ring used to treat signs and symptoms of vaginal atrophy in postmenopausal women.


METHODS
Randomized, double-blind, placebo-controlled, parallel treatment trial of raloxifene and placebo with open-label 17beta-estradiol ring. At 10 sites in the United States, 91 postmenopausal women with at least two signs of vaginal atrophy were treated with a 17beta-estradiol ring and randomized to receive concomitant raloxifene 60 mg/day or placebo for 6 months. Efficacy of treatments was evaluated by comparing investigator assessments of genitourinary atrophic signs, vaginal maturation value, and participant assessments of vaginal symptoms at 6 months. Other measures included rate and severity of hot flashes and assessment of sexual function. Uterine safety was assessed by endometrial biopsy and transvaginal ultrasound.


RESULTS
In women treated with a 17beta-estradiol ring, both the raloxifene and placebo treatment groups showed improvements in signs and symptoms of vaginal atrophy at 6 months, with no significant differences in degree of improvement between groups. There were no signs of endometrial proliferation in either group.


CONCLUSIONS
Concomitant administration of raloxifene does not alter the effects of the 17beta-estradiol ring on alleviating signs and symptoms of genitourinary atrophy in postmenopausal women.
Pinkerton
JoAnn V
JV
University of Virginia Health System, Charlottesville, VA, USA.
Shifren
Jan L
JL
La Valleur
June
J
Rosen
Amy
A
Roesinger
Mary
M
Siddhanti
Suresh
S
D000282:Administration, Intravaginal; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001284:Atrophy / Q000188:drug therapy / Q000473:pathology; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage / Q000627:therapeutic use*; D004965:Estrogen Antagonists / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008875:Middle Aged; D010570:Pessaries; D017698:Postmenopause; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage / Q000494:pharmacology*; D012720:Severity of Illness Index; D019529:Sexuality; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States; D014621:Vagina / Q000473:pathology*
D004965:Estrogen Antagonists; D020849:Raloxifene Hydrochloride; D004958:Estradiol