{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,24]],"date-time":"2026-02-24T06:58:06Z","timestamp":1771916286000,"version":"3.50.1"},"reference-count":36,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2023,2,14]],"date-time":"2023-02-14T00:00:00Z","timestamp":1676332800000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Reckitt Benckiser Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,3,31]]},"abstract":"Abstract<\/jats:title>Background<\/jats:title>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.<\/jats:p><\/jats:sec>Aim<\/jats:title>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.<\/jats:p><\/jats:sec>Methods<\/jats:title>An open-label, parallel-design study was performed in women aged 18 to 65\u00a0years 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\u00a0weeks of use as an indicator of lubricant performance.<\/jats:p><\/jats:sec>Outcomes<\/jats:title>The primary outcome was change from baseline in total FSFI score after 4\u00a0weeks of product use.<\/jats:p><\/jats:sec>Results<\/jats:title>A total of 174 women completed the study. The primary end point\u2014a prespecified increase in FSFI \u22654 points from baseline after 4\u00a0weeks of use\u2014was met by all 5 lubricants tested. A statistically significant improvement was observed across all 6 domains of the FSFI from baseline to 4\u00a0weeks of use with all 5 lubricants (P\u2009&lt;\u2009.0001 for lubrication and pain reduction and P\u2009&lt;\u2009.05 for all other domains). No serious adverse events occurred in the study, and the tolerance of all 5 lubricants was good\/very good.<\/jats:p><\/jats:sec>Clinical Implications<\/jats:title>The efficacy and safety of the tested lubricants are not compromised when formulated to meet the WHO criterion of osmolality \u22641200\u00a0mOsm\/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.<\/jats:p><\/jats:sec>Strengths and Limitations<\/jats:title>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.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>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.<\/jats:p><\/jats:sec>","DOI":"10.1093\/jsxmed\/qdad005","type":"journal-article","created":{"date-parts":[[2023,2,14]],"date-time":"2023-02-14T03:44:50Z","timestamp":1676346290000},"page":"498-506","source":"Crossref","is-referenced-by-count":14,"title":["A randomized trial on the effectiveness and safety of 5 water-based personal lubricants"],"prefix":"10.1093","volume":"20","author":[{"given":"Santiago","family":"Palacios","sequence":"first","affiliation":[{"name":"Palacios Institute of Health and Women\u2019s Medicine , C\/Antonio Acu\u00f1a, 9 - 28009, Madrid , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah","family":"Hood","sequence":"additional","affiliation":[{"name":"Reckitt Benckiser Healthcare Ltd , Dansom Lane, Hull, Slough, HU8 7DS , United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Temitayo","family":"Abakah-Phillips","sequence":"additional","affiliation":[{"name":"Reckitt Benckiser Healthcare Ltd , Dansom Lane, Hull, Slough, HU8 7DS , United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nina","family":"Savania","sequence":"additional","affiliation":[{"name":"Reckitt Benckiser Healthcare Ltd , Dansom Lane, Hull, Slough, HU8 7DS , United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Krychman","sequence":"additional","affiliation":[{"name":"The Southern California Center for Sexual Health and Survivorship Medicine , PO BOX 2718, Newport Beach, CA 92659 , United 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