Prospective, multicenter, uncontrolled study on the effectiveness and safety of a hyaluronic acid water-based vaginal lubricant in alleviating vaginal dryness and dyspareunia

Abstract

Background

Vaginal dryness (VD) represents a significant concern affecting women across diverse life stages, encompassing both pre- and postmenopausal women at any age. Dyspareunia, defined by genital pain that can be experienced before, during, or after intercourse, is often associated with vaginal dryness.

Aim

This study aimed to evaluate the effectiveness and safety of a water-based vaginal lubricant with hyaluronic acid to reduce sexual discomfort associated with vaginal dryness.

Methods

A prospective, multicenter, uncontrolled clinical investigation was conducted over a three-month period in women aged 18 years or older experiencing pain or difficulty during sexual intercourse for whom the use of a vaginal lubricant was recommended.

Results

Significant improvements were observed in the FSFI scores, indicating enhanced sexual function (p < .001). Vaginal dryness symptoms, including irritation, dryness, itching, and dyspareunia, significantly decreased after product use (p < .001).

Clinical implications

This study contributes to the limited scientific knowledge on the application of lubricants in the context of symptoms associated with VD.

Strengths & limitations

In addition to the short study period, inherent limitations of the study design, and lack of placebo control, it is pertinent to acknowledge that some of the pros used in this study were not based on validated questionnaires. However, as far as we know, this study is the only one that analyzes well-being and sexual pleasure as results using a lubricant formulated with hyaluronic acid.

Conclusion

This tested vaginal lubricant with hyaluronic acid has demonstrated efficacy in improving vaginal dryness and female sexual function, particularly in reducing pain and improving lubrication during sexual intercourse, and showed a favorable safety profile, with minimal and transient adverse events.

Keywords:

• Vaginal dryness
• dyspareunia
• sexual intercourse
• lubricant
• hyaluronic acid

Authors’ contributions

RS-B: is one of the study designers, has participated in the elaboration and writing of the article and is the current corresponding author. MS-P: is one of the study designers, has carried out data collection and has participated on the conceptualization and writing of the manuscript and critical revision of it. The rest of the authors carried out the data collection and critical review of the manuscript. All authors read and approved the final manuscript.

Ethics approval and consent to participate

All patients provided written informed consent upon enrollment, signifying their voluntary participation in the study. The study protocol received approval from the independent ethics committee of the Grupo Hospitalario Quirónsalud-Catalunya at its meeting on April 04, 2022. This research adhered strictly to the principles delineated in the Helsinki Declaration and fully complied with the regulations stipulated in the EU General Data Protection Regulation (GDPR). In accordance with the guidelines outlined by the GDPR, stringent measures were implemented to ensure the proper anonymization and secure storage of all personal data, which were kept separate from the research results.

Disclosure statement

RS-B reports research funding from Astellas, Mitra, and Exeltis and personal fees from HR-Pharma, Seid, and Lacer, outside the submitted work. The rest of the authors declare no conflicts of interest.

Availability of data and materials

The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.