Feasibility Study of the NEW NORMA-SENSE

Sponsor

Carmel Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00324246

Collaborator

Lin Medical Center, Haifa (Other), Common Sense (Other)

160

Enrollment

Location

Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

160 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Sep 1, 2006

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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