Feasibility Study of the NEW NORMA-SENSE

This study has been completed.
Sponsor:
Collaborators:
Women Health Care Center - Lin Medical Center
Common Sense
Information provided by:
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00324246
First received: May 9, 2006
Last updated: June 19, 2008
Last verified: January 2007
  Purpose
  • 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 Phase
Vaginal Infection
Phase 3

Study Type: Observational
Study Design: 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.

Further study details as provided by Carmel Medical Center:

Biospecimen Retention:   None Retained

Vaginal secretions.


Enrollment: 160
Study Start Date: September 2006
Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324246

Locations
Israel
Women Health Care Center - Lin Medical Center
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
Women Health Care Center - Lin Medical Center
Common Sense
Investigators
Principal Investigator: Adam Geva, MD Women Health Care Center - Lin Medical Center, Haifa, Israel
  More Information

No publications provided

Responsible Party: hadar kessary, common sense
ClinicalTrials.gov Identifier: NCT00324246     History of Changes
Other Study ID Numbers: F-7-28-1 CTIL, CMC 06014008
Study First Received: May 9, 2006
Last Updated: June 19, 2008
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Carmel Medical Center:
vaginal infection
color appearance
new developed indicator strips (NEW NORMA-SENSE)
in-vitro
vaginal secretion
elevated pH

ClinicalTrials.gov processed this record on July 31, 2014