Acceptability of Lactacyd Femina - Full Text View

Acceptability of Lactacyd Femina (LACTAFEM)

This study has been completed.

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00712868

Purpose

To demonstrate the safety and acceptability of the gynaecological formulation.

Condition	Intervention	Phase
Hygiene	Drug: Lactic acid	Phase IV

Drug Information available for: Lactic acid Ammonium lactate

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Clinical and local tolerability [ Time Frame: After 21 days ] [ Designated as safety issue: No ]

Enrollment:	556
Study Start Date:	June 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lactic Acid once a day during 21 days	Drug: Lactic acid Once a day

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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: NCT00712868

Locations

Mexico
Sanofi aventis administrative office
Mexico, Mexico

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Judith Diaz, Md

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LACAC_L_03447
Study First Received:	July 7, 2008
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00712868
Health Authority:	Mexico: Ethics Committee

ClinicalTrials.gov processed this record on January 14, 2009