A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings

Menorrhagia Clinical Trial

Official title:

A Swedish Cross-sectional Study With Questionnaire to Investigate Perception of Menstrual Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643304
• Other study ID #: 16384
• Secondary ID: NN1223SE
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: November 20, 2013
• Start date: May 2012
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1547
• Est. completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 45 Years

Eligibility

Inclusion Criteria:

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

• Completion of the web-based questionnaire

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of subjectively experienced heavy menstrual bleeding assessed by questionnaire		Once at baseline	No
Secondary	Social consequences of heavy menstrual bleedings assessed by questionnaire		Once at baseline	No
Secondary	Costs; e.g. pads, absence from work, loss of income assessed by questionnaire		Once at baseline	No
Secondary	The treatments given for heavy menstrual bleedings, as surgery or medication assessed by questionnaire		Once at baseline	No

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