NCT00370162

Brief Summary

The purpose of this study is to demonstrate the safety of the gynaecological formulation in normal and usual usage condition.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2006

Completed
Last Updated

May 16, 2008

Status Verified

May 1, 2008

First QC Date

August 29, 2006

Last Update Submit

May 15, 2008

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

  • Adverse Events and its association with the drug in study

Interventions

lactoserumDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Integral skin in the tested region

You may not qualify if:

  • Pregnancy or breastfeeding women
  • Use of antiinflammatory or immunosuppression drugs
  • Topical medication use at the tested region
  • Active cutaneous gynaecological disease
  • Personal history of allergic disease at the area to be treated
  • Allergic or atopic history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

São Paulo, Brazil

Location

MeSH Terms

Interventions

lactoserum

Study Officials

  • Jaderson Lima

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2006

First Posted

August 30, 2006

Study Start

June 1, 2006

Last Updated

May 16, 2008

Record last verified: 2008-05

Locations

BR(1)