Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis
Phase 4
Completed
- Conditions
- Bacterial Vaginosis
- Interventions
- Drug: Lactoserum (Dermacyd Femina®)
- Registration Number
- NCT00556179
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 122
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Lactoserum (Dermacyd Femina®) -
- Primary Outcome Measures
Name Time Method Rate of recurrence of bacterial vaginosis after three months of treatment. Three months
- Secondary Outcome Measures
Name Time Method Quality of life Three months Vaginal Candidiasis Three months AE, particularly genital irritation (tolerability use of dermacyd) During the study
Trial Locations
- Locations (1)
Sanofi-aventis
🇧🇷São Paulo, Brazil