E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Bacterial Vaginosis (imbalance of vaginal flora) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10004055 |
E.1.2 | Term | Bacterial vaginosis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The principle objective of the study is to determine whether intravaginal lactic acid gel is better than oral metronidazole for symptomatic resolution of recurrent bacterial vaginosis. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are as follows: a. To compare the time to first recurrence of BV symptoms; b. To compare the frequency of BV episodes over 6 months; c. To compare the frequency of BV treatments required over 6 months; d. To compare microbiological resolution of BV on microscopy 2 weeks after presentation; e. To compare the tolerability profiles of lactic acid gel and metronidazole; f. To compare adherence to lactic acid gel versus metronidazole tablets; g. To compare acceptability of use of lactic acid gel versus metronidazole tablets; h. To determine comparative presence of concurrent sexually transmitted infections at baseline and at week 2; i. To compare quality of life (measured using the SF-12); j. To compare cost effectiveness of using intravaginal lactic acid gel versus oral metronidazole tablets
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal exclusion criteria |
1. Contra-indications or allergy to lactic acid gel or metronidazole tablets (see section 4.2.1 for details). 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is resolution of bacterial vaginosis based on participant reported resolution of symptoms at week 2.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Participant completed questionnaire for symptom resolution two weeks post randomisation.
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E.5.2 | Secondary end point(s) |
a. Time to first recurrence of BV; b. Number of participant reported BV episodes over 6 months; c. Number of participant reported BV treatment courses over 6 months; d. Microbiological resolution of BV on microscopy of vaginal smears at week 2; e. 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) and via participant interviews; f. Participant reported adherence to treatment; g. Acceptability of treatments via qualitative assessment in a subgroup of participants; h. Prevalence of concurrent sexually transmitted infections (gonorrhoea, chlamydia and trichomoniasis) at baseline and at week 2; i. Quality of life assessed by SF-12 questionnaire at baseline, 2 weeks, and 6 months; j. Comparative cost effectiveness of using intravaginal lactic acid gel versus oral metronidazole tablets via NHS Service use questionnaire.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
As per above: a. date of the first recurrence b. frequency of BV episodes over 6 months c. additional BV treatments taken over 6 months d. analysis of vaginal smears using Hay Ison assessment criteria. e. participant reporting of side effects including nausea, vomiting, taste disturbance, vaginal irritation, diarrhoea and abdominal pain at week 2. f. number of doses taken / missed reported by participant at week 2. g. qualitative assessment telephone interviews with participants (2-4 weeks post randomisation) h. screening for chlamydia, gonorrhoea and trichomoniasis via nucleic acid amplification tests (NAAT) on vaginal swabs taken at baseline and 2 weeks. i. SF-12 questionnaires at at baseline, 2 weeks, and 6 months; j. participant records healthcare usage at 2 weeks, 3 months & |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Lactic acid gel (CE marked medical device) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 40 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial will be one month after the expected date of return of the final participant completed 6 month questionnaire. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 30 |