A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01643304
• Collaborator: (none)
• Enrollment: 1,547
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 1518.9

Study Details

Study Description

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	Phase
Menorrhagia	Behavioral: No drug

Study Design

• 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 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Prevalence of subjectively experienced heavy menstrual bleeding assessed by questionnaire [Once at baseline]

Secondary Outcome Measures

1. Social consequences of heavy menstrual bleedings assessed by questionnaire [Once at baseline]

2. Costs; e.g. pads, absence from work, loss of income assessed by questionnaire [Once at baseline]

3. The treatments given for heavy menstrual bleedings, as surgery or medication assessed by questionnaire [Once at baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Sweden

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01643304
• Other Study ID Numbers: 16384; NN1223SE
• First Posted: Jul 18, 2012
• Last Update Posted: Nov 21, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Bayer: Menorrhagia; Heavy menstrual bleeding; Uterine Hemorrhage; Menstruation Disturbancies
• Additional relevant MeSH terms: Menorrhagia; Hemorrhage

Study Results

No Results Posted as of Nov 21, 2013