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Acceptability of Lactacyd Femina (LACTAFEM)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00712868
First received: July 7, 2008
Last updated: July 17, 2009
Last verified: July 2009
History of Changes
  Purpose

To demonstrate the safety and acceptability of the gynaecological formulation.


Condition Intervention Phase
Hygiene
 Drug: Lactic acid
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Lactacyd Femina

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

Enrollment: 559
Study Start Date: June 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lactic Acid once a day during 21 days
 Drug: Lactic acid
Once a day

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Integral skin in the tested region

Exclusion Criteria:

  • Pregnancy or breastfeeding women
  • Use of anti-inflammatory or immune-suppression drugs
  • Topical medication use at the tested region
  • Active cutaneous gynaecological disease which may interfere in study results
  • Personal history of allergic disease at the area to be treated
  • Allergic or atopic history

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
Col. Coyoacan, Mexico
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Judith Diaz, Md Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00712868     History of Changes
Other Study ID Numbers: LACAC_L_03447
Study First Received: July 7, 2008
Last Updated: July 17, 2009
Health Authority: Mexico: Ethics Committee

ClinicalTrials.gov processed this record on May 16, 2013