{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["24(9)"],"submitter":["Simon JA"],"pubmed_abstract":["Objective
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.Methods
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 va"],"journal":["Menopause (New York, N.Y.)"],"pagination":["1003-1010"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC5571882"],"repository":["biostudies-literature"],"pubmed_title":["Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial."],"pmcid":["PMC5571882"],"pubmed_authors":["Kagan R","Archer DF","Graham S","Bernick B","Mirkin S","Constantine GD","Simon JA"],"additional_accession":[]},"is_claimable":false,"name":"Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial.","description":"Objective
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.Methods
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 va","dates":{"release":"2017-01-01T00:00:00Z","publication":"2017 Sep","modification":"2026-05-01T15:06:59.101Z","creation":"2025-05-29T16:29:15.086Z"},"accession":"S-EPMC5571882","cross_references":{"pubmed":["28419068"],"doi":["10.1097/GME.0000000000000880"]}}