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

Bacterial Vaginosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556179
• Other study ID #: LACTO_L_02399
• Status: Completed
• Phase: Phase 4
• First received: November 8, 2007
• Last updated: January 21, 2009
• Start date: September 2007

Study information

• Verified date: January 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Lactoserum (Dermacyd Femina®)
Once a day during three months

Locations

Country	Name	City	State
Brazil	Sanofi-aventis	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrence of bacterial vaginosis after three months of treatment.		Three months	No
Secondary	Quality of life		Three months	No
Secondary	Vaginal Candidiasis		Three months	No
Secondary	AE, particularly genital irritation (tolerability use of dermacyd)		During the study	Yes