- 2024-02-15
- Minerva obstetrics and gynecology 76(4)
- Valerio Galli
- Tullio Golia D'Augè
- Francesco DI Pierro
- Massimiliano Cazzaniga
- Luigina Guasti
- Nicola Zerbinati
- Alexander Bertuccioli
- Amjad Khan
- Giulia D'Ovidio
- Francesco Iaculli
- Valentina Tibaldi
- Giusi Santangelo
- Margherita Fischetti
- Assunta F Casorelli
- Violante DI Donato
- Andrea Giannini
- Angela Musella
- Antonella Giancotti
- Marco Monti
Study Design
- Type
- Observational
- Population
- 50 menopausal women
- Methods
- single-center, open-label, prospective and observational study; gel administration daily for first 12 days and every 48 hours for remaining 138 days
- Blinding
- Open-label
- Duration
- 150 days
- Funding
- Unclear
Background
Despite the gold standard treatment for genitourinary syndrome of menopause (GSM) is based on the use of local or systemic estrogen-containing products, the typical long-term side effects of hormonal treatments and, most importantly, the contraindications in patients with history of breast and endometrial neoplasms do limit in some extent its use. As hyaluronic acid and some highly purified botanicals have clearly demonstrated their anti-inflammatory and mucosa-protecting properties, we have tested, in women with GSM, a class II vaginal medical device containing hyaluronate gel and a mucoadhesive active enriched with purified alkylamides from Zanthoxylum bungeanum, triterpenes from Centella asiatica and high molecular weight polysaccharides from Tamarindus indica.Methods
Our single-center, open-label, prospective and observational study was conducted on 50 menopausal women enrolled at the Department of Maternal-Fetal Medicine at Umberto I Polyclinic Hospital in Rome, Italy. Gel administration lasted 150 days and was performed daily for the first 12 days and every 48 hours for the remaining 138 days. Clinical evaluations were performed at baseline and after 12, 57 and 150 days. Besides product safety, main outcomes of our study were: 1) vaginal health (by Vaginal Health Index score [VHI]); 2) sexual quality of life (by Female Sexual Distress Scale [FSDS]); and 3) percentage of women declaring regular sexual activity.Results
The product was safe with no specific adverse events reported. It significantly improved VHI (about 5% after 57 days and 8% after 150 days), FSDS (about 7% after 57 days and 10% after 150 days), and sexual activity (about 20% after 150 days). It also reduced dryness, dyspareunia, burning, itching, and dysuria incidence, respectively by about 18%, 14%, 14%, 27% and 11% after 150 days.Conclusions
In women with GSM, the intravaginal administration of a hyaluronate-based gel enriched with purified botanical actives endowed with anti-inflammatory and mucosal-protecting properties, reduced painful sensation during sexual acts and increased regular sexual activity.