biostudies-literatureUnknown24(9)Simon JA<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 self-administered vaginally once per day for 2 weeks, then twice per week for 10 weeks. The vagina was visually examined at baseline and at weeks 2, 6, 8, and 12; changes were evaluated using a 4-item scale for vaginal color, vaginal epithelial integrity, vaginal epithelial surface thickness, and vaMenopause (New York, N.Y.)1003-1010https://www.ebi.ac.uk/biostudies/studies/S-EPMC5571882biostudies-literatureVisual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial.PMC5571882Kagan RArcher DFGraham SBernick BMirkin SConstantine GDSimon JAfalseVisual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial.<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 self-administered vaginally once per day for 2 weeks, then twice per week for 10 weeks. The vagina was visually examined at baseline and at weeks 2, 6, 8, and 12; changes were evaluated using a 4-item scale for vaginal color, vaginal epithelial integrity, vaginal epithelial surface thickness, and va2017-01-01T00:00:00Z2017 Sep2026-05-01T15:06:59.101Z2025-05-29T16:29:15.086ZS-EPMC55718822841906810.1097/GME.0000000000000880