Acceptability of Lactacyd Femina

NCT ID: NCT00712868

Last Updated: 2009-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

559 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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To demonstrate the safety and acceptability of the gynaecological formulation.

Detailed Description

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Conditions

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Hygiene

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Lactic Acid once a day during 21 days

Group Type EXPERIMENTAL

Lactic acid

Intervention Type DRUG

Once a day

Interventions

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Lactic acid

Once a day

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Judith Diaz, Md

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Col. Coyoacan, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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LACAC_L_03447

Identifier Type: -

Identifier Source: org_study_id

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