Real‑world performance and safety of vaginal ovules in reducing the vaginal symptoms associated with vulvovaginal atrophy and postmenopausal sexual dysfunction.

Abstract

Decreasing estrogen 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 occurs in postmenopausal patients. The present study (trial no. NCT05654610) was designed as an observational, multicenter, real-world clinical investigation to evaluate the performance and safety of the medical device Halova® ovules in decreasing vaginal symptoms associated with vulvovaginal atrophy and sexual dysfunction. A total of 249 female participants were treated with Halova ovules, both in monotherapy and in combination with vaginal lubricants. The primary objective was to evaluate the tolerability of Halova 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 was defined a secondary objective. Halova ovules were rated with 'excellent' clinical performance by 92.74% of participants as a standalone treatment and 95.71% of the study participants when used in association with vaginal lubricants. Sexual dysfunction-associated parameters, such as vaginal dryness and dyspareunia, were reduced by similar percentages in each arm, 82% (monotherapy) and 80% (polytherapy) for vaginal dryness and 72% in monotherapy vs. 48% polytherapy reducing dyspareunia. No adverse reactions associated with treatment with Halova were reported. The medical device demonstrated anti-atrophic activity in the genitourinary tract, resulting in significantly improved symptoms associated with normal sexual functioning.