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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
History of Changes

May 9, 2006
June 19, 2008
September 2006
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Complete list of historical versions of study NCT00324246 on ClinicalTrials.gov Archive Site
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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

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.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   None Retained
Description:

Vaginal secretions.
Probability Sample

Women, age between 18 years and 45 years with or without symptoms of vaginal infection.
Vaginal Infection
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
December 2007
Not Provided

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.
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00324246
F-7-28-1 CTIL, CMC 06014008
Yes
hadar kessary, common sense
Carmel Medical Center
  • Women Health Care Center - Lin Medical Center
  • Common Sense
Principal Investigator: Adam Geva, MD Women Health Care Center - Lin Medical Center, Haifa, Israel
Carmel Medical Center
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP