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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556179
First Posted: November 9, 2007
Last Update Posted: January 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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: 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556179


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00556179     History of Changes
Other Study ID Numbers: LACTO_L_02399
First Submitted: November 8, 2007
First Posted: November 9, 2007
Last Update Posted: January 22, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Recurrence
Vaginal Diseases
Vaginosis, Bacterial
Disease Attributes
Pathologic Processes
Genital Diseases, Female
Bacterial Infections
Vaginitis
Immune Sera
Immunologic Factors
Physiological Effects of Drugs