Bacterial vaginosis (BV) Urological and Genital Diseases Bacterial vaginosis (BV)
Conditions
Interventions
At their single clinic visit, participants are asked to provide initial samples for analysis of BV and will then will be randomised to receive either:
1. Intravaginal lactic acid gel used once daily f
Sponsors
University Hospitals Birmingham NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age 16 years or over 2. Clinical diagnosis of bacterial vaginosis – based on patient reported symptoms of discharge with an unpleasant (typically fishy) odour (with or without positive microscopy according to local site practice) 3. History of at least one previous episode of bacterial vaginosis within the past two years (clinically diagnosed or patient reported) which resolved with treatment 4. Willing to use either intravaginal lactic acid gel or oral tablets for the management of BV 5. Willing to take their own vaginal samples 6. Willing to avoid vaginal douching during treatment 7. Willing to provide contact details and be contacted for the purpose of collecting follow-up information 8. Willing to avoid sexual intercourse or use effective contraception for the 7-day duration of study treatment (condoms are not considered to be effective contraception due to a potential interaction with lactic acid gel) 9. Access to the internet, email and willing to complete web based follow up questionnaires in English 10. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Contra-indications or allergy to lactic acid gel or metronidazole tablets 2. Pregnant or breastfeeding 3. Patients currently trying to conceive and not willing to avoid sexual intercourse or use effective contraception for the 7-day duration of study treatment 4. Use of oral antibiotics (other than the study treatment) or antifungal agents; concurrently, within the last 2 weeks or planned use within the next 2 weeks 5. Use of topical vaginal antibiotics, antifungals or acidifying products (other than the study treatment) concurrently, within the last 2 weeks, or planned use within the next 2 weeks 6. Previous participation in this study 7. Current participation in another clinical trial involving an investigational medicinal product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of bacterial vaginosis based on participant reported resolution of symptoms at week 2 (14 days from randomisation). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first recurrence of BV is measured using patient reported questionnaires over 6 months 2. Number of participant reported BV episodes is measured using patient reported questionnaires over 6 months 3. Number of participant reported BV treatment courses is measured using patient reported questionnaires over 6 months 4. Microbiological resolution of BV is measured using microscopy of vaginal smears at week 2 5. Comparative tolerability of lactic acid gel and metronidazole assessed by participant reporting of side effects (including nausea, vomiting, taste disturbance, vaginal irritation, diarrhoea and abdominal pain) using patient reported questionnaire at 2 weeks and via participant interviews post intervention 6. Participant reported adherence to treatment is measured using participants reports at 2 weeks 7. Acceptability of treatments via qualitative assessment in a subgroup of participants post intervention 8. Prevalence of concurrent sexually transmitted infections (gonorrhoea, chlamydia and trichomoniasis) at baseline and at week 2 9. Quality of life is assessed by SF-12 questionnaire at baseline, 2 weeks and 6 months 10. Comparative cost effectiveness measured via NHS Service use questionnaire at week 2, 3 and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed