Performance Proof of the New NORMA-SENSE
1 other identifier
observational
224
1 country
1
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 secretion with an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE strip results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedDecember 5, 2008
December 1, 2008
5 months
December 4, 2008
December 4, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
We will asses agreement between the color status of the NORMA-SENSE as reported by the subject after using the panty liner, and the pH measurement with Nitrazine paper.
1 week
Study Arms (1)
vaginitis
Interventions
Should be used by the clinician. the test usage will take up to 6 hours. The result reading will take few second.
Eligibility Criteria
Women, age greater then 18 without symptoms of vaginal infection.
You may qualify if:
- Women, age 18 years or greater without symptoms of vaginal infection.
- Subject is ready to sign the informed consent form.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lin Medical center
Haifa, Israel
Biospecimen
VAGINAL SECRETIONS
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 4, 2008
First Posted
December 5, 2008
Study Start
February 1, 2009
Primary Completion
July 1, 2009
Study Completion
August 1, 2009
Last Updated
December 5, 2008
Record last verified: 2008-12