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

Local, National (Brazil), Multicentric, Open, Non-Controlled, Phase IV, Study of Lactoserum (Dermacyd Femina®), in Women at Reproductive Age, to Prevent Recurrence of Bacterial Vaginosis, During Three Months, After Standard Treatment With Metronidazole.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00556179
Enrollment
122
Registered
2007-11-09
Start date
2007-09-30
Completion date
Unknown
Last updated
2009-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis

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.

Interventions

DRUGLactoserum (Dermacyd Femina®)

Once a day during three months

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Rate of recurrence of bacterial vaginosis after three months of treatment.Three months

Secondary

MeasureTime frame
Quality of lifeThree months
Vaginal CandidiasisThree months
AE, particularly genital irritation (tolerability use of dermacyd)During the study

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026