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A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 16, 2012
First Posted Date July 18, 2012
Last Update Posted Date November 21, 2013
Study Start Date May 2012
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: July 17, 2012)
Prevalence of subjectively experienced heavy menstrual bleeding assessed by questionnaire [ Time Frame: Once at baseline ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2012)
  • Social consequences of heavy menstrual bleedings assessed by questionnaire [ Time Frame: Once at baseline ]
  • Costs; e.g. pads, absence from work, loss of income assessed by questionnaire [ Time Frame: Once at baseline ]
  • The treatments given for heavy menstrual bleedings, as surgery or medication assessed by questionnaire [ Time Frame: Once at baseline ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings
Official Title A Swedish Cross-sectional Study With Questionnaire to Investigate Perception of Menstrual Bleeding
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects included in the SIFO (Swedish institute of market research) volontary subject pool.
Condition Menorrhagia
Intervention 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.
Study Groups/Cohorts Group 1
Intervention: Behavioral: No drug
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 17, 2012)
1547
Original Actual Enrollment Same as current
Actual Study Completion Date June 2012
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: Female
Ages 40 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01643304
Other Study ID Numbers 16384
NN1223SE ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2013