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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00556179
Other study ID # LACTO_L_02399
Secondary ID
Status Completed
Phase Phase 4
First received November 8, 2007
Last updated January 21, 2009
Start date September 2007

Study information

Verified date January 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Drug:
Lactoserum (Dermacyd Femina®)
Once a day during three months

Locations

Country Name City State
Brazil Sanofi-aventis São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

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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