Sánchez-Prieto Manuel, Mendoza Nicolás, Chedraui Peter, Lugo-Salcedo Félix, Serra-Ribas Aida, Aladrén-Pérez Sonia, Bustos-Santafé Javier, Sánchez-Borrego Rafael
DiaTrecnon, Woman's Clinic, Gynecology and Obstetrics, Teknon Medical Center, Barcelona, Spain.
Department of Obstetrics & Gynaecology, Faculty of Medicine, University of Granada, Granada, Spain.
Gynecol Endocrinol. 2025 Dec;41(1):2500480. doi: 10.1080/09513590.2025.2500480. Epub 2025 May 5.
To evaluate the efficacy and safety of a non-hormonal vaginal moisturizer in alleviating the clinical symptoms of vulvovaginal atrophy (VVA).
This was an observational, single center, open label study in which the investigational product was applied to postmenopausal women ( = 36) with VVA symptoms three times per week for a period of 12 weeks. Patient's perception of vaginal discomfort, sexual function improvement assessed with the Female Sexual Function Index (FSFI), quality of life evaluated with the Cervantes-SF scale, and subject's satisfaction with the treatment were evaluated after 4 and 12 weeks of product use. In addition, vaginal health was evaluated with the Vaginal Health Index (VHI) score and the vaginal pH.
A statistically significant decrease was observed in the severity of the most bothersome symptoms from moderate at baseline (mean 2.47 ± 0.55) to mild after 4 weeks (mean 1.33 ± 0.58) and 12 weeks (mean 1.32 ± 0.74, < 0.0001). VHI scores significantly improved after 4 and 12 weeks compared to baseline (from 11.70 to 16.36 at 4 weeks and 17.34 at 12 weeks, both < 0.0001). Vaginal pH decreased significantly from a mean pH of 6.27 ± 0.46 at baseline to 5.77 ± 0.59 at 4 weeks and 5.56 ± 0.60 at 12 weeks of treatment ( < 0.0001). Total FSFI scores significantly increased, indicating improvement of sexual function, after 4 and then after 12 weeks of product use (Baseline score 20.16 compared to 24.27 at 4 and 23.94 at 12 weeks, both < 0.0001). Quality of life improved (decrease of total Cervantes-SF scores) after 12 weeks of product use as compared to baseline (Baseline 32.09 vs 26.45, = 0.0004). At 12 weeks, a 97.5% reported overall satisfaction with the product and no adverse events related to the product were reported.
Through limited size study, the proposed non-hormonal vaginal moisturizer demonstrated being effective and safe for the management of VVA symptoms in postmenopausal women, offering significant improvements in symptom severity, vaginal health, sexual function, and quality of life. There is a need for further research with a larger sample and comparison with other similar products.
评估一种非激素阴道保湿剂缓解外阴阴道萎缩（VVA）临床症状的疗效和安全性。
这是一项观察性、单中心、开放标签研究，将研究产品每周三次应用于36名有VVA症状的绝经后女性，为期12周。在使用产品4周和12周后，评估患者对阴道不适的感知、用女性性功能指数（FSFI）评估的性功能改善情况、用塞万提斯 - SF量表评估的生活质量以及受试者对治疗的满意度。此外，用阴道健康指数（VHI）评分和阴道pH值评估阴道健康状况。
观察到最困扰症状的严重程度从基线时的中度（平均2.47±0.55）在4周后降至轻度（平均1.33±0.58），并在12周后保持轻度（平均1.32±0.74，P<0.0001）。与基线相比，VHI评分在4周和12周后显著改善（4周时从11.70提高到16.36，12周时为17.34，两者P<0.0001）。阴道pH值从基线时的平均6.27±0.46在治疗4周时显著降至5.77±0.59，在12周时降至5.56±0.60（P<0.0001）。在使用产品4周后，然后在12周后，FSFI总分显著增加，表明性功能改善（基线评分20.16，4周时为24.27，12周时为23.94，两者P<0.0001）。与基线相比，在使用产品12周后生活质量得到改善（塞万提斯 - SF总分降低）（基线32.09对26.45，P = 0.0004）。在12周时，97.5%的人报告对产品总体满意，未报告与产品相关的不良事件。
通过有限规模的研究，所提出的非激素阴道保湿剂对绝经后女性VVA症状的管理显示出有效且安全，在症状严重程度、阴道健康、性功能和生活质量方面有显著改善。需要进行更大样本量的进一步研究，并与其他类似产品进行比较。
