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DOI: 10.1101/2023.05.17.23290093

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

D. G.Iliescu R. Petrita C. Teodorescu R. A. Olaru A. D. Toma
Decreasing of sex hormones during postmenopausal period results in atrophy of the tissues and physiological changes, such as thinning of the vaginal epithelium, prolapse, decreased pelvic floor strength and control. Sexual disfunction, correlated with vaginal dryness is frequently reported among postmenopausal women. The present study was designed as an observational, multicentric, real-world evidence clinical investigation to evaluate the performance and safety of the medical device Halova ovules in reducing the vaginal symptoms associated with vulvovaginal atrophy and sexual disfunction. A total of 249 female participants were treated with Halova ovules, both in single therapy and associated with concomitant medication. The primary objective was to evaluate the tolerability of Halova ovules in the management of symptoms associated with perimenopause or with genitourinary syndrome of menopause. The evolution of clinical manifestations such as vaginal dryness, dysuria, dyspareunia and endometrial thickness in patients with aforementioned conditions were defined as secondary objectives. Halova ovules was rated with excellent clinical performance for 92.74% of study participants as a standalone treatment and for 95.71% of study participants when used in association. Sexual disfunction related parameters, such as vaginal dryness and dyspareunia were reduced, with similar percentages in each arm. There have been no reported adverse reactions related to the treatment with Halova. Halova might be a therapeutic alternative in patients in whom local estrogenic treatment remains controversial, such as patients with breast cancer. The study and its details are registered with number NCT05654610.