A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01643304
First received: July 16, 2012
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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 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:


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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01643304     History of Changes
Other Study ID Numbers: 16384, NN1223SE
Study First Received: July 16, 2012
Last Updated: November 20, 2013
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 April 22, 2014