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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00933699 |
Primary Objective:
To prove the safety of the gynaecological formulation in normal conditions of use.
Condition | Intervention | Phase |
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Hygiene |
Drug: LACTIC ACID(ND) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up - Dermacyd PH_DESILSTY_FL (Lactic Acid). |
Enrollment: | 31 |
Study Start Date: | June 2009 |
Study Completion Date: | July 2009 |
Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Dermacyd PH_DESILSTY_FL (Lactic Acid): Experimental
Treatment duration: 21 consecutive days
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Drug: LACTIC ACID(ND)
Treatment duration: 21 consecutive days
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | LACAC_L_04803 |
Study First Received: | July 3, 2009 |
Last Updated: | September 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00933699 History of Changes |
Health Authority: | Brazil: National Health Surveillance Agency |