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A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings

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ClinicalTrials.gov Identifier: NCT01643304
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
This 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 or disease Intervention/treatment
Menorrhagia Behavioral: No drug

Study Type : Observational
Actual Enrollment : 1547 participants
Time Perspective: Cross-Sectional
Official Title: A Swedish Cross-sectional Study With Questionnaire to Investigate Perception of Menstrual Bleeding
Study Start Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. Prevalence of subjectively experienced heavy menstrual bleeding assessed by questionnaire [ Time Frame: Once at baseline ]

Secondary Outcome Measures :
  1. Social consequences of heavy menstrual bleedings assessed by questionnaire [ Time Frame: Once at baseline ]
  2. Costs; e.g. pads, absence from work, loss of income assessed by questionnaire [ Time Frame: Once at baseline ]
  3. The treatments given for heavy menstrual bleedings, as surgery or medication assessed by questionnaire [ Time Frame: Once at baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 45 Years   (Adult)
Sexes 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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643304


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01643304     History of Changes
Other Study ID Numbers: 16384
NN1223SE ( Other Identifier: Company Internal )
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013

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