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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Bacterial Vaginosis

Treatments: Drug: Lactoserum (Dermacyd Femina®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00556179

LACTO_L_02399

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Lactoserum (Dermacyd Femina®)