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

Sanofi122 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

122

Conditions

Bacterial Vaginosis

Interventions

Lactoserum (Dermacyd Femina®)DRUG

Once a day during three months

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-aventis

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

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

Time frame: Three months

Secondary Outcomes

Quality of life

Time frame: Three months

Vaginal Candidiasis

Time frame: Three months

AE, particularly genital irritation (tolerability use of dermacyd)

Time frame: During the study

Data from ClinicalTrials.gov

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