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 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.
RCT Entities:
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 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.
Authors: Sang Jun Han; Khurshida Begum; Charles E Foulds; Ross A Hamilton; Suzanna Bailey; Anna Malovannaya; Doug Chan; Jun Qin; Bert W O'Malley Journal: Mol Pharmacol Date: 2015-10-20 Impact factor: 4.436
Authors: Charles E Wood; Jay R Kaplan; M Babette Fontenot; J Koudy Williams; J Mark Cline Journal: Clin Cancer Res Date: 2010-01-26 Impact factor: 12.531
Authors: James A Simon; David F Archer; Risa Kagan; Brian Bernick; Shelli Graham; Ginger D Constantine; Sebastian Mirkin Journal: Menopause Date: 2017-09 Impact factor: 2.953
Authors: David D Rahn; Holly E Richter; Vivian W Sung; Wilma I Larsen; Linda S Hynan Journal: Female Pelvic Med Reconstr Surg Date: 2021-01-01 Impact factor: 1.913