Treatment of vulvovaginal atrophy is associated with high levels of satisfaction and improves symptom severity and patient-reported outcomes: 12-month results of the PatieEnt satisfactiON studY (PEONY)

OBJECTIVE: To evaluate whether the benefits demonstrated after 6 months of treating vulvovaginal atrophy (VVA) with ospemifene and local vaginal estrogen therapy (LET) were maintained after 12 months. To assess the persistence and adherence to treatments, as well as the satisfaction of participants and associated factors. METHODS: Longitudinal, observational study conducted in 17 Italian gynecology centers involving women already under treatment (LET or ospemifene) or new users. Participants complete questionnaires at baseline (T0), after 3 (T3), 6 (T6), and 12 months (T12). The main outcome measures were treatment satisfaction, severity of symptoms, Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and Short Form-12 (SF-12) Health Survey. RESULTS: Among the 385 women included in the study, 145 (37.7%) were treated with ospemifene, and 240 (62.3%) with LET. Overall, 75.9% of women treated with ospemifene and 78.7% with LET completed the 12-month follow-up. In the ospemifene group, the treatment satisfaction score improved from 7.02 (95% CI, 6.64-7.39) at T3 to 8.32 (95% CI, 7.78-8.86) at T12 ( P