Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
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, see Learn About Clinical Studies.

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 November 20, 2014