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.
Design: Randomized, double-blind, placebo-controlled, parallel treatment trial of raloxifene and placebo with open-label 17β-estradiol ring. At 10 sites in the United States, 91 postmenopausal women with at least two signs of vaginal atrophy were treated with a 17β-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 17β-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 17β-estradiol ring on alleviating signs and symptoms of genitourinary atrophy in postmenopausal women.
From the 1University of Virginia Health System, Charlottesville, VA; 2Massachusetts General Hospital, Boston, MA; 3University of Minnesota, Minneapolis, MN; and 4Eli Lilly and Company, Indianapolis, IN.
Received April 8, 2002; revised and accepted July 2, 2002.
This work was supported by Eli Lilly and Company.
Address reprint requests to JoAnn V. Pinkerton, MD, The Women's Place Midlife Health Center, University of Virginia Health System, 2955 Ivy Road, Suite 104, PO Box 801104, Charlottesville, VA 22908-1104. E-mail: jvpinkerton@Virginia.edu.