Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial
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, 17Ī²-estradiol softgel capsule (TX-004HR 4, 10, and 25āĪ¼g) 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 vaginal secretions.
Results: Significant improvements were observed with all three TX-004HR doses versus placebo in vaginal color (least square mean score changes of ā0.96 to ā1.06 for TX-004HR doses vs ā0.60 for placebo at week 12), epithelial integrity (ā0.97 to ā1.07 vs ā0.60), epithelial surface thickness (ā0.94 to ā1.03 vs ā0.61), and secretions (ā1.01 to ā1.06 vs ā0.64) (Pā
Source: Menopause - Category: OBGYN Tags: Original Articles Source Type: research