Validate QUEM MethodMEVA-1NCT01276964
Protocol for the Determination of Menstrual Losses in Healthy Women With Apparently Normal Cycles
An observational study of Validate QUEM Method and Quantitative Determination of Menses, run by University of L'Aquila at 3 sites in Italy.
Trial summary
Multicenter, observational, cross-over study intended to apply an easy and simple system for the quantitative determination of menstrual losses in women with apparently normal menses.The system adopted for the determination of menstrual losses, called QUEM (QUantitative Evaluation of Menses), is based on the… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Validate QUEM Method, Quantitative Determination of Menses
- How many people
- 150 participants
- Where
- 3 sitesItaly
- Study dates
- Sep 2007to Sep 2012
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women in the fertile age with apparently normal cycles
Who may be able to join
- Women in the fertile age (between 20-45 years), not assuming oral contraceptives from at least three months
- Referred normal menses .Use of the same brand of sanitary protection wear for the whole of the period.
- BMI between 18 and 30
Who cannot join
- Abnormal Bleeding Score
- Positive gynecological history of fibroids, polyps or malignancy
- Treatment with anti-coagulants, antifibrinolytics, non steroidal anti-inflammatory agents
- Use of oral contraceptives in past three months
- Use of intrauterine devices (IUDs) in past three months .Hgb levels <12 g/dl and Ferritin <25 ng/ml.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 2 recruiting
- Recruiting
University of L'Aquila
L’Aquila, 67100
napolitano, marysanta@libero.it
napolitano mariasanta, md
- Active, not recruiting
University of Palermo
Palermo, Italy, 90127
- Recruiting
Casa Sollievo Della Sofferenza Irccs
San Giovanni Rotondo, Italy, 71013
grandone, grandone@katamail.com
elvira grandone, md
About this study
Official title: Protocol for the Determination of Menstrual Losses Using a System for the Quantitative Determination of Menses (Quantitative Evaluation of Menses [QUEM] Method) and Its Application to Healthy Women With Apparently Normal Cycles
Multicenter, observational, cross-over study intended to apply an easy and simple system for the quantitative determination of menstrual losses in women with apparently normal menses.The system adopted for the determination of menstrual losses, called QUEM (QUantitative Evaluation of Menses), is based on the collection of tampons and pads in standard bags which are readily vacuum sealed with a simple device for the whole of woman's period. The evaluation will be performed for the whole of one period and the analysis will be performed in comparison to the classical reference method, the Alkaline - Hematin Method, which is still considered the golden standard.
Read the detailed description
The following is a multicenter, observational, cross-over study intended to apply an easy and simple system for the quantitative determination of menstrual losses in women with apparently normal menses. The problem of heavy periods is associated to an high social and physical morbidity rate; till now there are not routine methods available for the quantitative determination of menstrual discharge, some objective methods have been applied exclusively for research purposes because they are very difficult to perform. If we consider the scientific data available and the frequent application of inadequate procedures for the treatment of this problem, it seems essential to apply a practical system for the accurate quantitative determination of menses.
The system adopted for the determination of menstrual losses, called QUEM (QUantitative Evaluation of Menses), is based on the collection of tampons and pads in standard bags which are readily vacuum sealed with a simple device for the whole of woman's period. QUEM has already been validated in preliminary in vitro and ex vivo studies (both in healthy women and in women with CBDs), by comparing it with the gold standard, the Alkaline Haematin Method. A correlation coefficient close to 1 was obtained.
In the current study QUEM will be applied to at least 100 women in the fertile age (between 20 and 45 years) with apparently normal menses and a negative bleeding history. The evaluation will be performed for the whole of one period and the analysis will be performed in comparison to the classical reference method, the Alkaline - Hematin Method, which is still considered the golden standard. At the enrollment each woman will be tested for complete blood cells count and ferritin levels in order to exclude unknown menorrhagia. The bleeding history (bleeding score) will be performed by applying an international reference method, already validated for von Willebrand Disease type 1 (vWD1). The aim of the study is to make a "normal range" and validate the effective practicality of QUEM as a preliminary step to the clinical studies in patients suffering from menorrhagia and affected by hemorrhagic disorders.
The current study will involve many Italian and International Centers. All the needed materials and equipments will be provided by the Coordinator Centre; patients will be carefully informed about the objectives of the study and they will follow a short course illustrating the use and the characteristics of the method proposed (QUEM).
- Keywords
- menses, quantitative determination of menstrual losses, kinetic definition of menses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. Women in the fertile age | Healthy women in the fertile age (between 20-45 years) with apparently normal periods |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startSep 2007
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validate QUEM MethodStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Collaborators
- Casa Sollievo della Sofferenza IRCCS, University of Palermo
- Responsible party
- Principal investigator, Guglielmo Mariani, University of L'Aquila
- Investigators
- mariasanta napolitano, md, Principal investigator, univeristy of perugia, hospital of l'aquilaguglielmo mariani, md, Study director, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276964
- Sponsor's protocol ID
- MEVA-1/2007
- Acronym
- MEVA-1
- Status last verified
- Jul 2012
- First submitted
- 11 Jan 2011
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Determination of Menstrual Losses Using a System for the Quantitative Determination of Menses (Quantitative Evaluation of Menses [QUEM] Method) and Its Application to Healthy Women With Apparently Normal Cycles
- ClinicalTrials.gov ID
- NCT01276964
- Acronym / sponsor ID
- MEVA-1 / MEVA-1/2007
- Keywords
- menses, quantitative determination of menstrual losses, kinetic definition of menses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Collaborators
- Casa Sollievo della Sofferenza IRCCS, University of Palermo
- Study start
- Sep 2007
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 14 Jan 2011 (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.
Multicenter, observational, cross-over study intended to apply an easy and simple system for the quantitative determination of menstrual losses in women with apparently normal menses.The system adopted for the determination of menstrual losses, called QUEM (QUantitative Evaluation of Menses), is based on the collection of tampons and pads in standard bags which are readily vacuum sealed with a simple device for the whole of woman's period. The evaluation will be performed for the whole of one period and the analysis will be performed in comparison to the classical reference method, the Alkaline - Hematin Method, which is still considered the golden standard.
Detailed description
The following is a multicenter, observational, cross-over study intended to apply an easy and simple system for the quantitative determination of menstrual losses in women with apparently normal menses. The problem of heavy periods is associated to an high social and physical morbidity rate; till now there are not routine methods available for the quantitative determination of menstrual discharge, some objective methods have been applied exclusively for research purposes because they are very difficult to perform. If we consider the scientific data available and the frequent application of inadequate procedures for the treatment of this problem, it seems essential to apply a practical system for the accurate quantitative determination of menses.
The system adopted for the determination of menstrual losses, called QUEM (QUantitative Evaluation of Menses), is based on the collection of tampons and pads in standard bags which are readily vacuum sealed with a simple device for the whole of woman's period. QUEM has already been validated in preliminary in vitro and ex vivo studies (both in healthy women and in women with CBDs), by comparing it with the gold standard, the Alkaline Haematin Method. A correlation coefficient close to 1 was obtained.
In the current study QUEM will be applied to at least 100 women in the fertile age (between 20 and 45 years) with apparently normal menses and a negative bleeding history. The evaluation will be performed for the whole of one period and the analysis will be performed in comparison to the classical reference method, the Alkaline - Hematin Method, which is still considered the golden standard. At the enrollment each woman will be tested for complete blood cells count and ferritin levels in order to exclude unknown menorrhagia. The bleeding history (bleeding score) will be performed by applying an international reference method, already validated for von Willebrand Disease type 1 (vWD1). The aim of the study is to make a "normal range" and validate the effective practicality of QUEM as a preliminary step to the clinical studies in patients suffering from menorrhagia and affected by hemorrhagic disorders.
The current study will involve many Italian and International Centers. All the needed materials and equipments will be provided by the Coordinator Centre; patients will be carefully informed about the objectives of the study and they will follow a short course illustrating the use and the characteristics of the method proposed (QUEM).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. Women in the fertile age | – | –Healthy women in the fertile age (between 20-45 years) with apparently normal periods |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women in the fertile age with apparently normal cycles
Key inclusion criteria (3 listed)
- Women in the fertile age (between 20-45 years), not assuming oral contraceptives from at least three months
- Referred normal menses .Use of the same brand of sanitary protection wear for the whole of the period.
- BMI between 18 and 30
Key exclusion criteria (5 listed)
- Abnormal Bleeding Score
- Positive gynecological history of fibroids, polyps or malignancy
- Treatment with anti-coagulants, antifibrinolytics, non steroidal anti-inflammatory agents
- Use of oral contraceptives in past three months
- Use of intrauterine devices (IUDs) in past three months .Hgb levels <12 g/dl and Ferritin <25 ng/ml.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- The official site of Italian Society of Obstetrics and GynecologyLink provided by the sponsor.
- Official site of the American Society of Obstetrics and Gynecology for women's healthcare physiciansLink provided by the sponsor.
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.
mariasanta napolitano, md principal investigator
univeristy of perugia, hospital of l'aquila
guglielmo mariani, md study director
University of L'Aquila
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validate QUEM Method and Quantitative Determination of Menses, run by University of L'Aquila at 3 sites in Italy.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact guglielmo mariani, md (0862368208, gmprivate39@gmail.com), or a site near the patient. 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 16 Jul 2012.