Bacterial Vaginosis Clinical Trial
Official title:
Local, National (Brazil), Multicentric, Open, Non-Controlled, Phase IV, Study of Lactoserum (Dermacyd Femina®), in Women at Reproductive Age, to Prevent Recurrence of Bacterial Vaginosis, During Three Months, After Standard Treatment With Metronidazole.
Verified date | January 2009 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Health Surveillance Agency |
Study type | Interventional |
The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence of bacterial vaginosis after three months of the standard treatment.
Status | Completed |
Enrollment | 122 |
Est. completion date | |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Women in reproductive age - Confirmed cure of bacterial vaginosis after treatment with oral metronidazole. - Vaginal bacterioscopic examination negative for candida and trichomonas. Exclusion Criteria: - Pregnant or breastfeeding women - Allergy to dermacyd The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Sanofi-aventis | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of recurrence of bacterial vaginosis after three months of treatment. | Three months | No | |
Secondary | Quality of life | Three months | No | |
Secondary | Vaginal Candidiasis | Three months | No | |
Secondary | AE, particularly genital irritation (tolerability use of dermacyd) | During the study | Yes |
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