Real-world performance and safety of Halova(R) ovules in reducing the vaginal symptoms associated with vulvovaginal atrophy and postmenopausal sexual disfunction

Decreasing sex hormones levels during the postmenopausal period results in tissue atrophy and physiological changes, such as thinning of the vaginal epithelium, prolapse, and decreased pelvic floor strength and control. Sexual dysfunction associated with vaginal dryness has frequently been reported in postmenopausal women. The present study was designed as an observational, multicenter, real-world clinical investigation to evaluate the performance and safety of the medical device Halova(R) ovules in reducing vaginal symptoms associated with vulvovaginal atrophy and sexual dysfunction. A total of 249 female participants were treated with Halova(R) ovules, both in monotherapy and in combination with concomitant medication. The primary objective of this study was to evaluate the tolerability of Halova(R) ovules in the management of symptoms associated with perimenopause or genitourinary syndrome of menopause. The evolution of clinical manifestations such as vaginal dryness, dysuria, dyspareunia, and endometrial thickness in patients with the aforementioned conditions was defined as a secondary objective. Halova(R) ovules were rated with "excellent" clinical performance by 92.74% of the study participants as a standalone treatment and 95.71% of the study participants when used in association. Sexual dysfunction-related parameters, such as vaginal dryness and dyspareunia, were reduced by similar percentages in each arm. No adverse reactions related to treatment with Halova(R) have been reported. Halova(R) may be a therapeutic alternative for patients with controversial local estrogenic treatment. The study and its details are registered with NCT05654610.