NCT00556179

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

January 22, 2009

Status Verified

January 1, 2009

Enrollment Period

1.3 years

First QC Date

November 8, 2007

Last Update Submit

January 21, 2009

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

  • Rate of recurrence of bacterial vaginosis after three months of treatment.

    Three months

Secondary Outcomes (3)

  • Quality of life

    Three months

  • Vaginal Candidiasis

    Three months

  • AE, particularly genital irritation (tolerability use of dermacyd)

    During the study

Study Arms (1)

1

EXPERIMENTAL
Drug: Lactoserum (Dermacyd Femina®)

Interventions

Lactoserum (Dermacyd Femina®)DRUG

Once a day during three months

1

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women in reproductive age
  • Confirmed cure of bacterial vaginosis after treatment with oral metronidazole.
  • Vaginal bacterioscopic examination negative for candida and trichomonas.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

lactoserum

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jaderson Lima

    Sanofi-aventis administrative office Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2008

Last Updated

January 22, 2009

Record last verified: 2009-01

Locations

BR(1)