Bacterial Vaginoses Clinical Trial
Official title:
Treatment of Bacterial Vaginosis With Dequalinium Chloride Vaginal Tablets and a Test of Cure Using a New Molecular Diagnostic Test for the Diagnosis of Bacterial Vaginosis
NCT number | NCT04057482 |
Other study ID # | 2050 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | April 2018 |
Verified date | August 2019 |
Source | Skaraborg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
. Treatment with dequalinium chloride vaginal tablets for 6 days had a cure rate lower than expected; only 37% of patients were considered cured one month after treatment.
Status | Completed |
Enrollment | 58 |
Est. completion date | April 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: BV Exclusion Criteria: No other infection (Gc, clhlamydia, trihomonas) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Skaraborg Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cure rate of BV | how many that are cured of BV after 1 month | 1 year | |
Secondary | Diagnosis of BV using molecular test | the Kappa index Hay/ison diagnosis and the molecular test | 1 year |
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