Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00556179

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 IV

Drug Information available for: Metronidazole Metronidazole hydrochloride Metronidazole phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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-Aventis:

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 ]

Estimated Enrollment:	101
Study Start Date:	September 2007
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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

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

Locations

Brazil
Sanofi-aventis
São Paulo, Brazil

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Jaderson Lima

Sanofi-aventis administrative office Brazil

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LACTO_L_02399
Study First Received:	November 8, 2007
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00556179
Health Authority:	Brazil: National Health Surveillance Agency

Study placed in the following topic categories:

Genital Diseases, Female
Bacterial Infections
Metronidazole
Vaginosis, Bacterial

Vaginitis
Vaginal Diseases
Recurrence

ClinicalTrials.gov processed this record on January 15, 2009