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Feasibility Study of the NEW NORMA-SENSE

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ClinicalTrials.gov Identifier: NCT00324246
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : June 20, 2008
Sponsor:
Collaborators:
Lin Medical Center, Haifa
Common Sense
Information provided by:
Carmel Medical Center

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 Phase
Vaginal Infection Phase 3

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
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 : September 2006
Study Completion Date : December 2007



Biospecimen Retention:   None Retained
Vaginal secretions.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324246


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

Responsible Party: hadar kessary, common sense
ClinicalTrials.gov Identifier: NCT00324246     History of Changes
Other Study ID Numbers: F-7-28-1 CTIL
CMC 06014008
First Posted: May 10, 2006    Key Record Dates
Last Update Posted: June 20, 2008
Last Verified: January 2007

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