Feasibility Study of the NEW NORMA-SENSE

Vaginal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324246
• Other study ID #: F-7-28-1 CTIL
• Secondary ID: CMC 06014008
• Status: Completed
• Phase: Phase 3
• First received: May 9, 2006
• Last updated: June 19, 2008
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: January 2007
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Vaginal Infection

Locations

Country	Name	City	State
Israel	Women Health Care Center - Lin Medical Center	Haifa

Sponsors (3)

Lead Sponsor	Collaborator
Carmel Medical Center	Common Sense, Lin Medical Center, Haifa

Country where clinical trial is conducted

Israel,