ArticleToxicology reports2018
Hyperosmolal vaginal lubricants markedly reduce epithelial barrier properties in a three-dimensional vaginal epithelium model.
Article in Toxicology reports, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 32 papers, 1 of them a synthesis that pooled it.
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The trial behind it
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Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it, 56 citations in OpenAlex.
- Lactic acid-containing products for bacterial vaginosis and their impact on the vaginal microbiota: A systematic review.PloS one · 2021Pooled it
- Formulation Development of Topical Inserts Containing Doxycycline and Doxycycline Combined with Tenofovir Alafenamide and Elvitegravir for the Prevention of Sexually Transmitted Infections.AAPS PharmSciTech · 2026Article
- Distinct properties of human pathogenicmSystems · 2026Article
- Defining benchmarking in the context of safety assessment of personal care and cosmetic products using New Approach Methodologies.NAM journal · 2026Review
- Artificial neural network guided optimization of tenofovir and Cyanovirin-N multipurpose preventive hydrogel formulation developed using the Box Behnken design model.Pharmaceutical science advances · 2025Article
- Prevalence of Amsel-Defined Bacterial Vaginosis Before and After Transvaginal Ultrasound With Lubricant Application.Sexually transmitted diseases · 2025Article
- Bacterial Vaginosis Incidence Following a Single Hyperosmolal Vaginal Lubricant Exposure: A Comparison of Two Observational Cohorts.Sexually transmitted diseases · 2025Observational
- Assessment of the vaginal microbiota before and after use of hyperosmolal lubricant during transvaginal ultrasound.American journal of obstetrics and gynecology · 2025Article
- Hypotonic, gel-forming delivery system for vaginal drug administration.Journal of controlled release : official journal of the Controlled Release Society · 2024Article
- Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices.Frontiers in drug safety and regulation · 2024Article
- Non Clinical Model to Assess the Mechanism of Action of a Combined Hyaluronic Acid, Chondroitin Sulfate and Calcium Chloride: HA+CS+CaClMedical devices (Auckland, N.Z.) · 2024Article
- Investigating the impact of condomless vaginal intercourse and lubricant use on the vaginal metabolome: a pre-post observational study.Sexually transmitted infections · 2023Observational
- Hydrogels for Mucosal Drug Delivery.ACS applied bio materials · 2023Review
- Vaginal Sheets withGels (Basel, Switzerland) · 2023Article
- Characterization of an air-liquid interface primary human vaginal epithelium to study Ebola virus infection and testing of antivirals.Antiviral research · 2023Article
- In vitro and ex vivo models for evaluating vaginal drug delivery systems.Advanced drug delivery reviews · 2022Review
- Toxicity Assessment of Resveratrol Liposomes-in-Hydrogel Delivery System by EpiVaginalPharmaceutics · 2022Article
- Inhaled antibodies: Quality and performance considerations.Human vaccines & immunotherapeutics · 2022Review
- Article
- Synergistic effects of carvacrol, α-terpinene, γ-terpinene, ρ-cymene and linalool against Gardnerella species.Scientific reports · 2022Article
Corrections and comments
- Erratum issued
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Most of the widely used vaginal lubricants in the U.S. and Europe are strongly hyperosmolal, formulated with high concentrations of glycerol, propylene glycol, polyquaternary compounds or other ingredients that make these lubricants 4 to 30 times the osmolality of healthy vaginal fluid. Hyperosmolal formulations have been shown to cause marked toxicity to human colorectal epithelia in vivo, and significantly increase vaginal transmission of genital herpes infections in the mouse/HSV model. They also cause toxicity to explants of vaginal epithelia, to cultured vaginal epithelial cells, and increase susceptibility to HIV in target cells in cell cultures. Here, we report that the osmolality of healthy vaginal fluid is 370 ± 40 mOsm/Kg in women with Nugent scores 0-3, and that a well-characterized three-dimensional human vaginal epithelium tissue model demonstrated that vaginal lubricants with osmolality greater than 4 times that of vaginal fluid (>1500 mOsm/Kg) markedly reduce epithelial barrier properties and showed damage in tissue structure. Four out of four such lubricants caused disruption in the parabasal and basal layers of cells as observed by histological analysis and reduced barrier integrity as measured by trans-epithelial electrical resistance (TEER). No epithelial damage to these layers was observed for hypo- and iso-osmolal lubricants with osmolality of <400 mOsm/Kg. The results confirm extensive reports of safety concerns of hyperosmolal lubricants and suggest the usefulness of reconstructed in vitro vaginal tissue models for assessing safety of lubricants in the absence of direct clinical tests in humans.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.