Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis

NCT ID: NCT00556179

Last Updated: 2009-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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

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Conditions

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Bacterial Vaginosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Lactoserum (Dermacyd Femina®)

Intervention Type DRUG

Once a day during three months

Interventions

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Lactoserum (Dermacyd Femina®)

Once a day during three months

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Jaderson Lima

Role: STUDY_DIRECTOR

Sanofi-aventis administrative office Brazil

Locations

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Sanofi-aventis

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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LACTO_L_02399

Identifier Type: -

Identifier Source: org_study_id

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