Feasibility Study of the NEW NORMA-SENSE

Completed

• Conditions: Vaginal Infection

• Registration Number: NCT00324246
• Lead Sponsor: Carmel Medical Center

Brief Summary

* In-vitro study

* Collect data regarding the color appearance on the new developed indicator strips (NEW NORMA-SENSE), in contact with vaginal secretion with elevated pH

* Measure the buffering capacity of vaginal secretion from non-symptomatic and symptomatic subjects

* Detect these indicator strips' performance, in contact with urine

Detailed Description

This in-vitro study was designed to collect data regarding the color appearance on the new developed indicator strips (NEW NORMA-SENSE) when coming in contact, in-vitro, with vaginal secretion with elevated pH, and to measure the buffering capacity of vaginal secretion from non-symptomatic subjects and symptomatic subjects, and to detect these indicator strips' performance when come in contact with urine.

Study Timeline

• Study First Submitted: 2006-05-09
• Study First Submitted QC: 2006-05-09
• Study First Posted: 2006-05-10
• Study Start: 2006-09
• Status Verified: 2007-01
• Study Completion: 2007-12
• Last Update Submitted: 2008-06-19
• Last Update Posted: 2008-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

1. Women, aged between 18 and 45, with or without symptoms of vaginal infection.
2. Subjects are ready to sign the informed consent form.

Exclusion Criteria

1. Subjects are unable or unwilling to cooperate with the study procedures.
2. Subjects are currently participating in another clinical study that may directly or indirectly affect the results of this study.
3. Subjects that suffer from vaginal bleeding or menstruate.
4. Subjects that have had sexual relations within the last 12 hours.
5. Subjects that applied local antiseptic, antibiotic or vaginal treatment within the last 3 days.
6. Subjects that applied vaginal douching within 12 hours prior to the visit at the clinic.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Women Health Care Center - Lin Medical Center; 🇮🇱 Haifa, Israel