ArticleEuropean journal of obstetrics & gynecology and reproductive biology: X2021
A phase 3, randomized, controlled trial of Astodrimer 1% Gel for preventing recurrent bacterial vaginosis.
Article in European journal of obstetrics & gynecology and reproductive biology: X, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 26 citations in OpenAlex.
- Probiotics reduce the recurrence of asymptomatic bacterial vaginosis in Chinese women.Scientific reports · 2025Trial
- Astodrimer sodium antiviral nasal spray for reducing respiratory infections is safe and well tolerated in a randomized controlled trial.Scientific reports · 2022Trial
- Advances in Dendrimer-Based Anti-Infective Systems: In Vivo Insights and Perspectives.Pharmaceutics · 2026Review
- Randomized trial of multi-strainContemporary clinical trials communications · 2025Article
- Genetic predictors for bacterial vaginosis in women living with and at risk for HIV infection.American journal of reproductive immunology (New York, N.Y. : 1989) · 2024Article
- The human vaginal microbiota: from clinical medicine to models to mechanisms.Current opinion in microbiology · 2024Review
- Bacterial vaginosis: a review of approaches to treatment and prevention.Frontiers in reproductive health · 2023Review
- In vitro and ex vivo models for evaluating vaginal drug delivery systems.Advanced drug delivery reviews · 2022Review
- Dendrimers, an Emerging Opportunity in Personalized Medicine?Journal of personalized medicine · 2022Review
- Astodrimer sodium and bacterial vaginosis: a mini review.Archives of gynecology and obstetrics · 2022Review
- The Role of Antimicrobial Resistance in Refractory and Recurrent Bacterial Vaginosis and Current Recommendations for Treatment.Antibiotics (Basel, Switzerland) · 2022Review
- Virucidal and antiviral activity of astodrimer sodium against SARS-CoV-2 in vitro.Antiviral research · 2021Article
- Topical Astodrimer Sodium, a Non-Toxic Polyanionic Dendrimer, Demonstrates Antiviral Activity in an Experimental Ocular Adenovirus Infection Model.Molecules (Basel, Switzerland) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe objective of the study was to confirm the efficacy and safety of Astodrimer 1% Gel to prevent recurrence of bacterial vaginosis. STUDY
design864 women with a diagnosis of bacterial vaginosis and a history of recurrent bacterial vaginosis were enrolled in North America and first received oral metronidazole (500 mg twice daily for 7 days). Women successfully treated with metronidazole were randomly assigned 1:1 to Astodrimer 1% Gel (N = 295) or placebo (N = 291) at a dose of 5 g vaginally every second day for 16 weeks, and followed for a further 12 weeks off-treatment. The primary endpoint was recurrence of bacterial vaginosis (presence of ≥3 Amsel criteria) at or by Week 16. Secondary endpoints included time to recurrence, and recurrence of subject-reported symptoms. Adverse events were monitored throughout the study.
resultsAstodrimer 1% Gel was superior to placebo for the primary and many secondary efficacy measures. At or by Week 16, bacterial vaginosis recurred in 44.2 % (130/294) of women receiving astodrimer and 54.3 % (158/291) receiving placebo (
conclusionsAstodrimer 1% Gel, administered every second day for 16 weeks, was effective and superior to placebo for prevention of recurrent bacterial vaginosis in women with a history of recurrent BV, and was well-tolerated.
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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.