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New trial will test effectiveness of treatment for bacterial vaginosis

Friday, 10 September 2021

Experts from the University of Nottingham and Leeds Teaching Hospitals NHS Trust are looking for women to take part in a clinical trial to test the effectiveness of a new treatment for bacterial vaginosis (BV).

BV causes a vaginal discharge that has an unpleasant smell. Up to a third of women will get it at some time in their lives. Treating BV is important as it can cause miscarriage, premature birth and an increased risk of catching HIV and other sexual infections.

Current BV treatment is not always effective and often symptoms return shortly after the treatment course is completed, with just over half of women getting their symptoms back within six months. The usual treatment is an oral antibiotic called metronidazole which can cause side-effects such as dizziness and nausea. Previous research has found that women with BV disliked taking antibiotics, especially on a regular basis, and they felt frustrated at the lack of alternative effective treatments.

Dr Janet Wilson, Consultant in Sexual Health at Leeds Teaching Hospitals NHS Trust, said: “Concern about frequent antibiotic use causing bacterial resistance means that non-antibiotic therapies are being considered for BV. There is a new treatment available for BV called dequalinium which works as a vaginal antiseptic. Its potential advantages are that it will not damage the good bacteria throughout the body or cause antibiotic resistance. Two previous studies have suggested that it could be an effective and safe treatment for BV but the number of women included were small so the results were not conclusive.”

Dequalinium is licensed for use as a BV treatment, but is not currently prescribed as a first line treatment in the UK. This new trial will look at whether dequalinium is as effective as the usual antibiotics in treating the symptoms of BV.

The team are looking for around 900 women to take part in the trial. To be eligible to take part, women must be 16 or older and have BV symptoms of vaginal odour, plus or minus discharge. All women must have their BV confirmed by microscopy prior to enrolling onto the trial.

Pregnant women can participate, unless they plan to seek a termination as this would require treatment with antibiotics.

Recruitment is open now via the trial website. Each participant will need to be involved for 12 weeks after they start the treatment. Patients can enter the trial through a recruitment centre (in person or remotely) or self-refer via the trial website.

This will be the first BV trial in the UK where women are able to participate without visiting a sexual health centre, GP or hospital. We have designed the trial, so that taking part is simple, making it possible for women to participate from the comfort of their own home. We hope this will encourage women who may not have access to a recruiting sexual health clinic, or who may be hesitant to visit a clinic about their symptoms, join our trial”
Rebecca Haydock, Trial Manager from the University of Nottingham’s Clinical Trial Unit

More information on the trial can be found here www.devastudy.ac.uk .

Story credits

More information is available from Rebecca Haydock, Senior Trial Manager, from Nottingham Clinical at the University at rebecca.haydock@nottingham.ac.uk

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