Protocol for the Determination of Menstrual Losses in Healthy Women With Apparently Normal Cycles

NCT01276964 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2012-07-16

No results posted yet for this study

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 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.

Conditions

  • Validate QUEM Method
  • Quantitative Determination of Menses

Sponsors & Collaborators

  • Casa Sollievo della Sofferenza IRCCS

    collaborator OTHER
  • University of Palermo

    collaborator OTHER
  • University of L'Aquila

    lead OTHER

Principal Investigators

  • mariasanta napolitano, md · univeristy of perugia, hospital of l'aquila

  • guglielmo mariani, md · University of L'Aquila

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01276964 on ClinicalTrials.gov