PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
NCT ID: NCT03187457
Last Updated: 2017-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-09-04
2017-11-14
Brief Summary
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Detailed Description
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* 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
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Treatment group
Metronidazole 400 mg 3 times daily for 5 days for Bacterial Vaginosis (BV) infection
Metronidazole
Women with Bacterial Vaginosis treated with Metronidazole for 5 days
Control group
Healthy women without Bacterial Vaginosis and without treatment
Control: no treatment
Healthy women without Bacterial Vaginosis
Interventions
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Metronidazole
Women with Bacterial Vaginosis treated with Metronidazole for 5 days
Control: no treatment
Healthy women without Bacterial Vaginosis
Eligibility Criteria
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Inclusion Criteria
* Female gender
* Over 18 years of age
* Have a high probability for compliance with and completion of the study
Exclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Community Pharmacology Services Ltd
OTHER
Danisco
INDUSTRY
Responsible Party
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Principal Investigators
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Gordon Crawford, MD
Role: PRINCIPAL_INVESTIGATOR
CPS Research
Locations
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CPS Research
Glasgow, , United Kingdom
Countries
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Other Identifiers
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NH-03708
Identifier Type: -
Identifier Source: org_study_id