Vaginal InfectionNCT00324246
Feasibility Study of the NEW NORMA-SENSE
An observational study of Vaginal Infection, run by Carmel Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Infection
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2006to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women, age between 18 years and 45 years with or without symptoms of vaginal infection.
Who may be able to join
- Women, aged between 18 and 45, with or without symptoms of vaginal infection.
- Subjects are ready to sign the informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Vaginal Infection
- Keywords
- vaginal infection, color appearance, new developed indicator strips (NEW NORMA-SENSE), in-vitro, vaginal secretion, elevated pH
- Medical subject headings
- Vaginitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2006 (estimated)
- Study startSep 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lin Medical Center, Haifa, Common Sense
- Investigators
- Adam Geva, MD, Principal investigator, Women Health Care Center - Lin Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324246
- Sponsor's protocol ID
- F-7-28-1 CTIL
- Other IDs
- CMC 06014008
- Status last verified
- Jan 2007
- First submitted
- 9 May 2006
- Last updated
- 20 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the NEW NORMA-SENSE Indicator Strip and Vaginal Secretion Buffer Capacity Measurement - IN-VITRO Study.
- ClinicalTrials.gov ID
- NCT00324246
- Acronym / sponsor ID
- F-7-28-1 CTIL
- Conditions
- Vaginal Infection
- Keywords
- vaginal infection, color appearance, new developed indicator strips (NEW NORMA-SENSE), in-vitro, vaginal secretion, elevated pH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- Lin Medical Center, Haifa, Common Sense
- Study start
- Sep 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 10 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women, age between 18 years and 45 years with or without symptoms of vaginal infection.
Key inclusion criteria (2 listed)
- Women, aged between 18 and 45, with or without symptoms of vaginal infection.
- Subjects are ready to sign the informed consent form.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Geva, MD principal investigator
Women Health Care Center - Lin Medical Center, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Infection, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2008.