A Randomized Trial on the Effectiveness of Five Water-Based Personal Lubricants in Premenopausal and Postmenopausal Women [ID: 1376759

Abstract

INTRODUCTION: Vaginal dryness is generally associated with postmenopausal women; however, it may occur at all ages. Personal lubricants can relieve discomfort associated with vaginal dryness, although clinical data supporting the efficacy of many lubricants are limited. METHODS: An open-label, parallel-design study was performed in heterosexual women in monogamous relationships, aged 18–65 years with mild-to-moderate vaginal dryness and dyspareunia. The study population (n=174) included an approximate 50:50 ratio of premenopausal to postmenopausal women. The randomization schedule was stratified by menopausal status. Participants were randomized to use one of five water-based lubricants and instructed to use their lubricant 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 total FSFI comprises six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain reduction. A greater than 4-point increase in total FSFI is considered clinically important. RESULTS: An increase in FSFI total score of greater than 4 points was found for all lubricants in the total population and for four of five lubricants in the premenopausal subgroup, as indicated by the mean differences to baseline. The number of participants in sexual function (total FSFI >26.55) after treatment was significantly greater than the number in sexual function before treatment for both subgroups (premenopausal, 19.3–78.4%; postmenopausal, 22.3–75.3%; P<.0001 for both). CONCLUSION: These lubricants can be used not only to relieve symptomatology of vaginal dryness and dyspareunia, but to enhance overall sexual satisfaction regardless of menopausal status.