Abstract

The softgel 17ß-estradiol (E2) vaginal inserts (4 and 10?µg; Imvexxy; TherapeuticsMD, Boca Raton, FL) are FDA approved for treating moderate to severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy (VVA). The objective here was to determine responder rates at week 2 and whether week-2 findings predicted week-12 responders in the REJOICE trial.Postmenopausal women received E2 vaginal inserts 4, 10, or 25?µg, or placebo for 12 weeks. Proportion of responders (having =2 of the following: vaginal superficial cells >5%, vaginal pH <5.0, or dyspareunia improvement of =1 category) were calculated. Odds ratios (ORs) for positive response at week 12 given a positive response at week 2 were determined in the efficacy evaluable (EE) population.The responder rate (in EE population [n?=?695]) was 74% to 82% with E2 inserts versus 24% with placebo at week 2, and 72% to 80% versus 33% at week 12. Positive treatment responses were 9- to 14-fold higher with vaginal E2 than with placebo at week 2, and 5- to 8-fold higher at week 12. Response at week 2 predicted response at week 12 in the total population (OR 13.1; 95% CI, 8.8-19.7) and with active treatment only (OR 7.9; 95% CI, 4.7-13.2).A high percentage of postmenopausal women with moderate to severe dyspareunia responded with the E2 softgel vaginal insert at week 2, and a positive response at week 2 predicted a positive response at week 12.

View details for DOI 10.1097/GME.0000000000001394

View details for PubMedID 31688572