Recurrence Clinical Trial
Official title:
A Pilot Study of Efficacy and Safety of Oral Metronidazole Versus Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent the Recurrence of Bacterial Vaginosis
Verified date | January 2021 |
Source | Peking University Shenzhen Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis
Status | Completed |
Enrollment | 66 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility | Inclusion Criteria: - Women be at least 18 years of age - Have symptoms of vaginal odor and or/discharge - Meet the clinical (Amsel) criteria for BV - Willing to participate in research Exclusion Criteria: - Presence of another vaginal infection or STD - Allergy to metronidazole - Pregnant or nursing - Use of oral or intravaginal antibiotics within the past 2 weeks - HIV or other chronic disease - Inability to keep return appointments - Contraindications for Lactobacillus Vaginal Suppositories(those without sexual history) |
Country | Name | City | State |
---|---|---|---|
China | Dept Obstetrics and Gynecology | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Peking University Shenzhen Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cure rate of BV | Nugent score | 4 weeks | |
Secondary | Recurrence of BV | Nugent score | 12 weeks | |
Secondary | Recurrence of BV | Nugent score | 24 weeks |
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