Back to resultsLactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis
Primary Purpose
Bacterial Vaginosis
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Lactoserum (Dermacyd Femina®)
Sponsored by
About this trial
This is an interventional prevention trial for Bacterial Vaginosis
Eligibility Criteria
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.
Sites / Locations
- Sanofi-aventis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Rate of recurrence of bacterial vaginosis after three months of treatment.
Secondary Outcome Measures
Quality of life
Vaginal Candidiasis
AE, particularly genital irritation (tolerability use of dermacyd)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00556179
Brief Title
Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lactoserum (Dermacyd Femina®)
Intervention Description
Once a day during three months
Primary Outcome Measure Information:
Title
Rate of recurrence of bacterial vaginosis after three months of treatment.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
Three months
Title
Vaginal Candidiasis
Time Frame
Three months
Title
AE, particularly genital irritation (tolerability use of dermacyd)
Time Frame
During the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaderson Lima
Organizational Affiliation
Sanofi-aventis administrative office Brazil
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis
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