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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00556179
First received: November 8, 2007
Last updated: January 21, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Bacterial Vaginosis
Drug: Lactoserum (Dermacyd Femina®)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Rate of recurrence of bacterial vaginosis after three months of treatment. [ Time Frame: Three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Three months ] [ Designated as safety issue: No ]
  • Vaginal Candidiasis [ Time Frame: Three months ] [ Designated as safety issue: No ]
  • AE, particularly genital irritation (tolerability use of dermacyd) [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Enrollment: 122
Study Start Date: September 2007
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Lactoserum (Dermacyd Femina®)
Once a day during three months

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556179

Locations
Brazil
Sanofi-aventis
São Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi-aventis administrative office Brazil
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00556179     History of Changes
Other Study ID Numbers: LACTO_L_02399
Study First Received: November 8, 2007
Last Updated: January 21, 2009
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Recurrence
Vaginosis, Bacterial
Disease Attributes
Pathologic Processes
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 30, 2014