Biomedical Reports · 6 authors, 6 centres
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This observational, multicenter study evaluated the real-world performance and safety of Halova vaginal ovules in 249 women with vulvovaginal atrophy and sexual dysfunction. After 10 days of treatment, participants reported high clinical performance ratings and significant reductions in symptoms like vaginal dryness and dyspareunia, with no adverse reactions reported.
This observational, multicenter, real-world clinical investigation (NCT05654610) enrolled 249 women with perimenopause or genitourinary syndrome of menopause to evaluate the tolerability and performance of Halova vaginal ovules. Participants received 10 ovules once daily for 10 days, either as monotherapy or combined with vaginal lubricants. The study found that 92.74% of participants rated the device as 'excellent' in monotherapy, and 95.71% in polytherapy. No adverse reactions were reported. Limitations include the absence of a control group, short follow-up, and population heterogeneity. The results suggest the device may be a safe, effective option for managing vulvovaginal atrophy symptoms, but long-term efficacy requires further study.
