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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00324246

Enrollment

160

Registered

2006-05-10

Start date

2006-09-30

Completion date

2007-12-31

Last updated

2008-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Infection

Keywords

vaginal infection, color appearance, new developed indicator strips (NEW NORMA-SENSE), in-vitro, vaginal secretion, elevated pH

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Countries

Israel

Outcome results