A randomized trial on the safety and efficacy of sensate water-based and silicone-based personal lubricants for relief of intimate discomfort associated with vaginal dryness.

Abstract

Background: Personal lubricants with different formulations and properties, including ingredients designed to enhance sensation or feeling, can be used to alleviate vaginal dryness and affect sexual function. Clinical data to support their safety and efficacy are limited.

Aim: Determine safety and efficacy of two sensate personal lubricants for relief of discomfort associated with vaginal dryness in female participants, and report the impact on sexual satisfaction in female participants and male partners.

Methods: A two-arm, parallel design study was performed in women (18-65 years) experiencing vaginal dryness. Participants were randomized to one of two sensate lubricants (water-based [tingling] or silicone-based [warming]), which had to be used during vaginal intercourse at least once a week over a 4-week period.

Outcomes: Primary outcome: change from baseline in total Female Sexual Function Index (FSFI) score after 4 weeks of lubricant use. Secondary outcomes: change from baseline in FSFI domain scores; adverse events (AE); vulvovaginal and oral tolerance; female participant and male partner perception of lubricants; improvement in sexual intimacy (assessed using Subject Perceived Questionnaires [SPQ] and Patient Global Impression of Change).

Results: Sixty-six female participants completed the study. The primary endpoint (prespecified increase in FSFI ≥4 points from baseline) was achieved for both lubricants. A positive change was observed across all six FSFI domains. All AEs were mild in severity; no serious AEs were reported; the discontinuation rate was 1.5% (one female participant; warming lubricant). For both lubricants, vulvovaginal tolerance was "good/very good" and oral tolerance was generally "very good" ("acceptable" for one participant in each treatment arm). For both lubricants, most female participants and their male partners agreed that first penetration during vaginal sex was smoother, and there was an improvement in sexual intimacy.

Clinical implications: Safety and efficacy of both lubricants containing sensate ingredients was demonstrated, giving reassurance that they can be safely recommended by healthcare professionals to relieve vaginal dryness and enhance sexual pleasure.

Strengths/limitations: Evidence is provided for the safety and efficacy of two sensate lubricants for relieving vaginal dryness and improving sexual pleasure in healthy participants across a wide age range. The SPQ is not a clinically validated tool, and the sample of participants was not diverse, which may limit the generalizability of data.

Conclusions: The use of sensate lubricants showed significant improvement in sexual function coupled with improved satisfaction for both male and female participants. No severe or serious AE were reported during the study period.