Palacios Institute of Health and Women's Medicine, C/Antonio Acuña, 9 - 28009, Madrid, Spain.
Reckitt Benckiser Healthcare Ltd, Dansom Lane, Hull, Slough, HU8 7DS, United Kingdom.
J Sex Med. 2023 Mar 31;20(4):498-506. doi: 10.1093/jsxmed/qdad005.
A range of personal lubricants with different formulations and subsequent properties are available for relief of discomfort associated with vaginal dryness; however, there are limited clinical data to support the efficacy and safety of many commercially available lubricants.
To determine the effectiveness and safety of 5 water-based personal lubricants for the relief of intimate discomfort associated with vaginal dryness in pre- and postmenopausal women: 4 that were formulated to meet the World Health Organization (WHO) guidelines for osmolality and pH and 1 preexisting lubricant of higher osmolality and pH.
An open-label, parallel-design study was performed in women aged 18 to 65 years with mild-to-moderate vaginal dryness and dyspareunia. Participants were randomized to 1 of 5 lubricants (A-E) from 3 brands (Durex, KY, Queen V). They were instructed to use their allocated lubricants during vaginal intercourse at least once a week over a 4-week period. The Female Sexual Function Index (FSFI) measured sexual functioning after 4 weeks of use as an indicator of lubricant performance.
The primary outcome was change from baseline in total FSFI score after 4 weeks of product use.
A total of 174 women completed the study. The primary end point-a prespecified increase in FSFI ≥4 points from baseline after 4 weeks of use-was met by all 5 lubricants tested. A statistically significant improvement was observed across all 6 domains of the FSFI from baseline to 4 weeks of use with all 5 lubricants (P < .0001 for lubrication and pain reduction and P < .05 for all other domains). No serious adverse events occurred in the study, and the tolerance of all 5 lubricants was good/very good.
The efficacy and safety of the tested lubricants are not compromised when formulated to meet the WHO criterion of osmolality ≤1200 mOsm/kg. The lubricants tested in this investigation can be used not only to relieve symptomatology of vaginal dryness and dyspareunia but also to enhance overall sexual satisfaction.
This study provides clinical evidence for the efficacy and safety of 5 lubricants, including those formulated to meet WHO guidelines, in relieving symptoms of vaginal dryness and improving the overall sexual experience. The open-label design may have introduced bias into the study.
All 5 lubricants, including those formulated to be compliant with guidelines on pH and osmolality, can be considered effective and well tolerated for the relief of discomfort associated with vaginal dryness.
有一系列配方和性能不同的个人润滑剂，可用于缓解与阴道干燥相关的不适；然而，许多市售润滑剂的疗效和安全性的临床数据有限。
评估 5 种不同配方的水基个人润滑剂在缓解绝经前和绝经后妇女阴道干燥相关不适症状的有效性和安全性：其中 4 种按照世界卫生组织（WHO）的渗透压和 pH 值标准进行配制，1 种为高渗透压和 pH 值的现有润滑剂。
对 18-65 岁有轻度至中度阴道干燥和性交痛的女性进行了一项开放标签、平行设计的研究。参与者被随机分配至 3 个品牌（杜蕾斯、KY、女王 V）的 5 种润滑剂（A-E）之一。他们被指示在 4 周内每周至少使用 1 次指定的润滑剂进行阴道性交。在使用 4 周后，女性性功能指数（FSFI）作为润滑剂性能的指标，评估女性的性健康。
共 174 名女性完成了研究。主要终点是在使用产品 4 周后，FSFI 总分较基线增加≥4 分，这一预设终点被所有 5 种测试的润滑剂均达到。所有 5 种润滑剂在使用 4 周后，FSFI 的所有 6 个领域均较基线有显著改善（润滑剂和疼痛缓解的 P<0.0001，其他所有领域的 P<0.05）。研究中未发生严重不良事件，所有 5 种润滑剂的耐受性均良好/非常好。
按照 WHO 渗透压标准≤1200 mOsm/kg 配制的这些润滑剂在缓解阴道干燥和性交痛方面的疗效和安全性没有受到影响。本研究中测试的润滑剂不仅可以缓解阴道干燥和性交痛的症状，还可以提高整体性满意度。
本研究为 5 种润滑剂（包括符合 WHO 指南的配方）缓解阴道干燥症状和改善整体性体验的疗效和安全性提供了临床证据。开放性设计可能会给研究带来偏倚。
