Ontology highlight
ABSTRACT:
SUBMITTER: Simon JA
PROVIDER: S-EPMC5571882 | biostudies-literature | 2017 Sep
REPOSITORIES: biostudies-literature
Simon James A JA Archer David F DF Kagan Risa R Bernick Brian B Graham Shelli S Constantine Ginger D GD Mirkin Sebastian S
Menopause (New York, N.Y.) 20170901 9
<h4>Objective</h4>To evaluate the response of the vaginal mucosa with TX-004HR and its correlation with vulvar and vaginal atrophy (VVA) symptoms, and whether visual examination is a useful measure for assessing VVA.<h4>Methods</h4>REJOICE was a 12-week, phase 3, multicenter, randomized, double-blind, placebo-controlled study of a vaginal, muco-adhesive, 17β-estradiol softgel capsule (TX-004HR 4, 10, and 25 μg) in postmenopausal women with VVA and moderate-to-severe dyspareunia. Treatments were ...[more]