Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019
Safety and Efficacy of a Novel Vaginal Anti-infective, TOL-463, in the Treatment of Bacterial Vaginosis and Vulvovaginal Candidiasis: A Randomized, Single-blind, Phase 2, Controlled Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02866227 (A Randomized Single Blind Safety and Efficacy Study of TOL-463 Vaginal Gel or Insert in the Treatment of Vaginitis), which is not on this map. Cited by 38 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Single Blind Safety and Efficacy Study of TOL-463 Vaginal Gel or Insert in the Treatment of Vaginitis (BV and/or VVC)
Who cites it
38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 84 citations in OpenAlex.
- Antibiofilm Agents for the Treatment and Prevention of Bacterial Vaginosis: A Systematic Narrative Review.The Journal of infectious diseases · 2024Pooled it
- Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021Guideline
- Intravaginal lactic acid gel versus oral metronidazole for treating women with recurrent bacterial vaginosis: the VITA randomised controlled trial.BMC women's health · 2023Trial
- Trial
- Vaginal formulations selectively target Lactobacillus iners and Candida spp. while preserving Lactobacillus crispatus.International microbiology : the official journal of the Spanish Society for Microbiology · 2026Article
- Microbiota Transplantation as a Future Novel Therapeutic Strategy Approach.Diseases (Basel, Switzerland) · 2026Review
- Integrating microbiome insights into cervical cancer.Frontiers in medicine · 2026Review
- Intravaginal boric acid treatment for recurrent bacterial vaginosis: short-term effects on vaginal health parameters and patient satisfaction.BMC women's health · 2025Observational
- Bacterial vaginosis.Nature reviews. Disease primers · 2025Review
- Deciphering the role of female reproductive tract microbiome in reproductive health: a review.Frontiers in cellular and infection microbiology · 2024Review
- Bacterial Vaginosis: Guideline of the DGGG, OEGGG and SGGG (S2k-Level, AWMF Registry No. 015/028, June 2023).Geburtshilfe und Frauenheilkunde · 2023Article
- Treatment of Vulvovaginal Candidiasis-An Overview of Guidelines and the Latest Treatment Methods.Journal of clinical medicine · 2023Review
- Fighting polymicrobial biofilms in bacterial vaginosis.Microbial biotechnology · 2023Review
- Bacterial Vaginosis and Post-Operative Pelvic Infections.Healthcare (Basel, Switzerland) · 2023Review
- Molecular association ofFrontiers in cellular and infection microbiology · 2023Review
- Understanding and Preventing Recurring Bacterial Vaginosis: Important Considerations for Clinicians.International journal of women's health · 2023Review
- Bacterial vaginosis: a review of approaches to treatment and prevention.Frontiers in reproductive health · 2023Review
- Review
- The right bug in the right place: opportunities for bacterial vaginosis treatment.NPJ biofilms and microbiomes · 2022Review
- Exploiting the Anti-Biofilm Effect of the Engineered Phage Endolysin PM-477 to Disrupt In Vitro Single- and Dual-Species Biofilms of Vaginal Pathogens Associated with Bacterial Vaginosis.Antibiotics (Basel, Switzerland) · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) present serious reproductive health risks and management challenges, with poor control attributed to survival of treatment-resistant biofilm communities. Boric acid is used in various regimens for non-albicans VVC and recurrent BV. We investigated safety and efficacy of a novel boric acid-based vaginal anti-infective with enhanced antibiofilm activity (TOL-463) in treating BV and VVC.
methodsIn this phase 2 randomized, investigator-blinded trial conducted at 2 sexual health clinics, women with BV or VVC were randomly assigned (1:1) to 7 nights of TOL-463 vaginal gel or insert. The primary test of cure (TOC) was clinical cure at day 9-12; safety was assessed at TOC and day 21-30.
resultsOne hundred six participants (53 with BV, 36 VVC, 17 both) were enrolled; most were African American (69%). Clinical cure rate of BV at TOC was 59% (95% confidence interval [CI], 41%-75%) for TOL-463 insert and 50% (95% CI, 31%-69%) for TOL-463 gel, and for VVC, 92% (95% CI, 67%-99%) for TOL-463 insert and 81% (95% CI, 57%-93%) for TOL-463 gel. Both products were safe and well tolerated with no secondary cases of VVC; vulvovaginal burning was the most common adverse event (9.6%).
conclusionsTOL-463, especially in vaginal insert form, is effective and safe in treating BV and VVC. Future studies should assess the potential role of TOL-463 as a biofilm disrupter in enhancing likelihood of cure relative to approved therapies, reducing recurrence rates, and combined with traditional antimicrobials. CLINICAL TRIALS REGISTRATION: NCT02866227.
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Registered trials
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.