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Completed

NCT Number: NCT00324246

Feasibility Study of the NEW NORMA-SENSE

* 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

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Key information

Conditions

Vaginal Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases Vaginitis

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Women Health Care Center - Lin Medical Center

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Collaborators

  • Common Sense
  • Lin Medical Center, Haifa

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
May 10, 2006
Registry last updated
Jun 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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