Objective: This study aimed to evaluate improvement of
dyspareunia and associated vaginal dryness with a 17β-estradiol softgel vaginal insert (TX-004HR; TherapeuticsMD, Boca Raton, FL, USA) in women with postmenopausal vulvar and vaginal
atrophy (VVA). Methods: Postmenopausal women with VVA and moderate to severe
dyspareunia received
TX-004HR (4, 10, or 25 μg) or placebo in the 12-week, randomized, double-blind, placebo-controlled, phase 3 REJOICE trial. Post hoc analyses examined improvement levels in
dyspareunia and concurrent vaginal dryness with
TX-004HR and assessed the effects of patient characteristics on vaginal dryness treatment. Results: Significantly more women treated with
TX-004HR (all doses) than placebo had complete resolution or substantial improvement in
dyspareunia or vaginal dryness (concurrent with
dyspareunia) by 12 weeks, observed as early as week 2 with most doses.
TX-004HR significantly improved both
dyspareunia and vaginal dryness at least one level versus placebo by week 12 in women with both symptoms. Subgroup analyses showed
TX-004HR improved vaginal dryness associated with
dyspareunia regardless of age, body mass index, uterine status, prior pregnancy, and vaginal birth number. Conclusion:
TX-004HR provided clinically meaningful improvements in
dyspareunia and vaginal dryness associated with
dyspareunia in postmenopausal women with VVA. Clinicians may be able to use this information when discussing patients' expectations regarding symptom improvement with the
estradiol vaginal insert.