A randomized trial on the effectiveness and safety of 5 water-based personal lubricants.

Background: 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.

Aim: 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.

Methods: 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.

Outcomes: The primary outcome was change from baseline in total FSFI score after 4 weeks of product use.

Results: 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.

Clinical Implications: 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.

Strengths And Limitations: 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.

Conclusion: 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.