Bacterial VaginosisPreFemNCT03187457
PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
A study testing Metronidazole in people with Bacterial Vaginosis, run by Danisco at 1 site in United Kingdom.
Trial summary
The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Sep 2017to 14 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Female gender
- Over 18 years of age
- Have a high probability for compliance with and completion of the study
Who cannot join
- Hypersensitivity to metronidazole --only applies to Group 2.
- Post-menopausal defined as at least 12 consecutive months without menstruation
- Treatment of BV in last 4 weeks
- Clinically significant menstrual irregularities
- Suspected presence of STDs or other vaginal infection
- Pregnancy
Show all 10Show fewer
- Breast feeding
- Participation in other clinical studies which could influence genitourinary tract microbiota
- Substance abuse
- Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).
Read the detailed description
This method validation study will endeavour to obtain evidence for:
- Recruitment methodology effectiveness
- The usefulness of the "Canestest" test as a screening tool
- The time required for the vaginal microbiota (particularly Lactobacillus count) to return to normal after treatment of BV infection with metronidazole.
- The time required for the Nugent Score to return to normal after treatment of BV infection with metronidazole.
- Conditions
- Bacterial Vaginosis
- Being tested
- Metronidazole, Control: no treatment
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleOther
Women with Bacterial Vaginosis treated with Metronidazole for 5 days
Control: no treatmentOther
Healthy women without Bacterial Vaginosis
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Other | Metronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection Receives: Other: Metronidazole |
| Control group | Other | Healthy women without Bacterial Vaginosis and without treatment Receives: Other: Control: no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vaginal microbiota assessed with sequencing
Change in vaginal microbiota is assessed with sequencing at 3 time points (baseline, at day 8 and at day 15 time points post antibiotic treatment.)
Measured: Baseline, at day 8, and at day 15
Secondary outcomes (2)
Vaginal microbiota/lactobacilli levels with Nugent scoring
Nugent scoring is used for the evaluation of the vaginal microbiota at baseline, at 8 and 15 day time points post antibiotic treatment.
Measured: Baseline, at day 8, and at day 15
Diagnosis of BV with "Canestest"
"Canestest" will be used to diagnose BV infection at baseline.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start4 Sep 2017
- Primary completion14 Nov 2017
- Study completion14 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Community Pharmacology Services Ltd
- Responsible party
- Sponsor
- Investigators
- Gordon Crawford, MD, Principal investigator, CPS Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187457
- Sponsor's protocol ID
- NH-03708
- Acronym
- PreFem
- Status last verified
- Dec 2017
- First submitted
- 18 May 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
- ClinicalTrials.gov ID
- NCT03187457
- Acronym / sponsor ID
- PreFem / NH-03708
- Conditions
- Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Collaborators
- Community Pharmacology Services Ltd
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).
Detailed description
This method validation study will endeavour to obtain evidence for:
- Recruitment methodology effectiveness
- The usefulness of the "Canestest" test as a screening tool
- The time required for the vaginal microbiota (particularly Lactobacillus count) to return to normal after treatment of BV infection with metronidazole.
- The time required for the Nugent Score to return to normal after treatment of BV infection with metronidazole.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Other | Other: MetronidazoleMetronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection |
| Control group | Other | Other: Control: no treatmentHealthy women without Bacterial Vaginosis and without treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Female gender
- Over 18 years of age
- Have a high probability for compliance with and completion of the study
Key exclusion criteria (10 listed)
- Hypersensitivity to metronidazole --only applies to Group 2.
- Post-menopausal defined as at least 12 consecutive months without menstruation
- Treatment of BV in last 4 weeks
- Clinically significant menstrual irregularities
- Suspected presence of STDs or other vaginal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetronidazoleWomen with Bacterial Vaginosis treated with Metronidazole for 5 days | Other | Treatment group |
| Control: no treatmentHealthy women without Bacterial Vaginosis | Other | Control group |
Primary outcome
Change in vaginal microbiota assessed with sequencing
Time frame: Baseline, at day 8, and at day 15
Change in vaginal microbiota is assessed with sequencing at 3 time points (baseline, at day 8 and at day 15 time points post antibiotic treatment.)
2 secondary outcomes
Vaginal microbiota/lactobacilli levels with Nugent scoring
Time frame: Baseline, at day 8, and at day 15
Diagnosis of BV with "Canestest"
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Individual participant dataSharing planned: No. No plan to share IPD
Related trials for Bacterial Vaginosis
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon Crawford, MD principal investigator
CPS Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metronidazole in people with Bacterial Vaginosis, run by Danisco at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vaginal microbiota assessed with sequencing (time frame: Baseline, at day 8, and at day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.