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Trial record 52 of 54 for:    "Vaginitis" | "Metronidazole"

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

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. Identifier: NCT00556179
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : January 22, 2009
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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.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: Lactoserum (Dermacyd Femina®) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
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.
Study Start Date : September 2007
Actual Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment
Experimental: 1 Drug: Lactoserum (Dermacyd Femina®)
Once a day during three months

Primary Outcome Measures :
  1. Rate of recurrence of bacterial vaginosis after three months of treatment. [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Three months ]
  2. Vaginal Candidiasis [ Time Frame: Three months ]
  3. AE, particularly genital irritation (tolerability use of dermacyd) [ Time Frame: During the study ]

Information from the National Library of Medicine

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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.

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 identifier (NCT number): NCT00556179

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

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00556179     History of Changes
Other Study ID Numbers: LACTO_L_02399
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009

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