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

Iliescu,Dominic-Gabriel; Petrita,Ramona; Teodorescu,Cristina; Olaru,Raluca Alexandra; Alexa,Andreea Anda; Petre,Izabella

doi:10.3892/br.2024.1723

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

Authors:
- Dominic-Gabriel Iliescu
- Ramona Petrita
- Cristina Teodorescu
- Raluca Alexandra Olaru
- Andreea Anda Alexa
- Izabella Petre
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Affiliations: Department of Obstetrics and Gynecology, University of Medicine and Pharmacy Craiova, 200349 Craiova, Romania, Biometrics Unit, MDX Research, 300633 Timisoara, Romania, Department of Obstetrics and Gynecology, ‘Nicolae Malaxa’ Clinical Hospital, 022441 Bucharest, Romania, Department of Obstetrics and Gynecology III, National Institute Alessandrescu Rusescu, Clinic of Obstetrics and Gynecology ‘Polizu’, 011061 Bucharest, Romania, Department of Biochemistry IV, University of Medicine and Pharmacy Victor Babes, 300041 Timisoara, Romania, Department of Obstetrics and Gynecology XII, University of Medicine and Pharmacy Victor Babes, 300041 Timisoara, Romania
Published online on: January 9, 2024 https://doi.org/10.3892/br.2024.1723
Article Number: 35
Copyright: © Iliescu et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

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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
in 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.

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