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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: November 8, 2007
Last updated: January 21, 2009
Last verified: January 2009
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: Intervention Model: Single Group Assignment
Masking: None (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.

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • 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 ]

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


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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.

  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 identifier: NCT00556179

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

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00556179     History of Changes
Other Study ID Numbers: LACTO_L_02399
Study First Received: November 8, 2007
Last Updated: January 21, 2009

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Disease Attributes
Pathologic Processes
Genital Diseases, Female
Bacterial Infections
Immune Sera
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017