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A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01643304
First received: July 16, 2012
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

This cross-sectional, field based, questionnaire study will document observational data on womens perception of menstrual bleeding in a cross-section of women in Sweden. Each subject will complete the questionnaire at one occasion.


Condition Intervention
Menorrhagia
 Behavioral: No drug

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: A Swedish Cross-sectional Study With Questionnaire to Investigate Perception of Menstrual Bleeding

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Prevalence of subjectively experienced heavy menstrual bleeding assessed by questionnaire [ Time Frame: Once at baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social consequences of heavy menstrual bleedings assessed by questionnaire [ Time Frame: Once at baseline ] [ Designated as safety issue: No ]
  • Costs; e.g. pads, absence from work, loss of income assessed by questionnaire [ Time Frame: Once at baseline ] [ Designated as safety issue: No ]
  • The treatments given for heavy menstrual bleedings, as surgery or medication assessed by questionnaire [ Time Frame: Once at baseline ] [ Designated as safety issue: No ]

Enrollment: 1547
Study Start Date: May 2012
Study Completion Date: June 2012
Groups/Cohorts Assigned Interventions
Group 1 Behavioral: No drug
No drug intervention. The intervention is a questionnaire with quality of life and perception of menstrual bleedings. All subjects will complete both questionnaires.

  Eligibility

Ages Eligible for Study:   40 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects included in the SIFO (Swedish institute of market research) volontary subject pool.

Criteria

Inclusion Criteria:

  • All women 40-45 years available in the web-panel of SIFO
  • Completion of the web-based questionnaire

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643304

Locations
Sweden
Many Locations, Sweden
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer AB
ClinicalTrials.gov Identifier: NCT01643304     History of Changes
Other Study ID Numbers: 16384, NN1223SE
Study First Received: July 16, 2012
Last Updated: November 16, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Bayer:
Menorrhagia
Heavy menstrual bleeding
Uterine Hemorrhage
Menstruation Disturbancies

Additional relevant MeSH terms:
Hemorrhage
Menorrhagia
Pathologic Processes
Uterine Hemorrhage
 Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances

ClinicalTrials.gov processed this record on May 22, 2013