Lasofoxifene Improves Vaginal Atrophy in Phase III Trial
Phase II studies have shown that lasofoxifene, a next-generation selective estrogen-receptor modulator, increased bone mineral density and improved both objective measures of vaginal atrophy and reported symptoms. Margery Gass, MD, and a team from the University of Cincinnati Medical Center reported yesterday that a double-blind, randomized, placebo-controlled Phase III trial produced similar results.
Phase II studies have shown that lasofoxifene, a next-generation selective estrogen-receptor modulator, increased bone mineral density and improved both objective measures of vaginal atrophy and reported symptoms. Margery Gass, MD, and a team from the University of Cincinnati Medical Center reported yesterday that a double-blind, randomized, placebo-controlled Phase III trial produced similar results.
A group of 445 postmenopausal women with symptomatic vaginal atrophy (VA) were randomly assigned to receive lasofoxifene (0.25 mg/day or 0.5 mg/day) or placebo. Clinical effect was assessed using vaginal pH and vaginal cytology to determine the maturation index (superficial, intermediate, and parabasal cells). At screening, women were required to have no more than 5% superficial cells and vaginal pH of more than 5.
The results were clear, Dr. Gass said. By week 12, there were adjusted mean decreases in parabasal cells of 38% for the lasofoxifene 0.25 group, 37% for the lasofoxifene 0.5 group, and 3% for the placebo group (P
Gass M, Kagan R, Simon J, Spino C, Barcomb L. Objective measures of vaginal atrophy are improved with lasofoxifene, a next-generation selective estrogen receptor modulator. Obstet Gynecol. 2005;105(4 suppl):71S.