Status:

UNKNOWN

Performance Proof of the New NORMA-SENSE

Lead Sponsor:

Carmel Medical Center

Conditions:

Vaginal Infection

Eligibility:

FEMALE

18-70 years

Brief Summary

This study was designed to validate the color appearance on the newly developed panty liner (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into contact with vaginal...

Eligibility Criteria

Inclusion

  • Women, age 18 years or greater without symptoms of vaginal infection.
  • Subject is ready to sign the informed consent form.

Exclusion

  • Subject is unable or unwilling to cooperate with study procedures.
  • Subject is currently participating in another clinical study.
  • Subject suffers from vaginal bleeding or is menstruating.
  • Subject that have had sexual relations within the last 12 hours.
  • Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days.
  • Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.

Key Trial Info

Start Date :

February 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2009

Estimated Enrollment :

224 Patients enrolled

Trial Details

Trial ID

NCT00802763

Start Date

February 1 2009

End Date

August 1 2009

Last Update

December 5 2008

Active Locations (1)

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1

Lin Medical center

Haifa, Israel