Feasibility Study of the NEW NORMA-SENSE

Feasibility Study of the NEW NORMA-SENSE Indicator Strip and Vaginal Secretion Buffer Capacity Measurement - IN-VITRO Study.

• 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

Study Overview

• Status: Completed
• Conditions: Vaginal Infection

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 Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Women Health Care Center - Lin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women, age between 18 years and 45 years with or without symptoms of vaginal infection.

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Collaborators: Common Sense; Lin Medical Center, Haifa
• Investigators: Principal Investigator: Adam Geva, MD, Women Health Care Center - Lin Medical Center, Haifa, Israel

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: May 9, 2006
• First Submitted That Met QC Criteria: May 9, 2006
• First Posted (Estimate): May 10, 2006

Study Record Updates

• Last Update Posted (Estimate): June 20, 2008
• Last Update Submitted That Met QC Criteria: June 19, 2008
• Last Verified: January 1, 2007

More Information

Terms related to this study

• Keywords: vaginal infection; in-vitro; color appearance; new developed indicator strips (NEW NORMA-SENSE); vaginal secretion; elevated pH
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: F-7-28-1 CTIL; CMC 06014008