NCT00324246

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 20, 2008

Status Verified

January 1, 2007

First QC Date

May 9, 2006

Last Update Submit

June 19, 2008

Conditions

Vaginal Infection

Keywords

vaginal infectioncolor appearancenew developed indicator strips (NEW NORMA-SENSE)in-vitrovaginal secretionelevated pH

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Women, aged between 18 and 45, with or without symptoms of vaginal infection.
  • Subjects are ready to sign the informed consent form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Care Center - Lin Medical Center

Haifa, Israel

Location

Biospecimen

Retention: NONE RETAINED

Vaginal secretions.

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Adam Geva, MD

    Women Health Care Center - Lin Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 10, 2006

Study Start

September 1, 2006

Study Completion

December 1, 2007

Last Updated

June 20, 2008

Record last verified: 2007-01

Locations

IL(1)