NCT01643304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,547

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

First QC Date

July 16, 2012

Last Update Submit

November 20, 2013

Conditions

Menorrhagia

Keywords

MenorrhagiaHeavy menstrual bleedingUterine HemorrhageMenstruation Disturbancies

Outcome Measures

Primary Outcomes (1)

  • Prevalence of subjectively experienced heavy menstrual bleeding assessed by questionnaire

    Once at baseline

Secondary Outcomes (3)

  • Social consequences of heavy menstrual bleedings assessed by questionnaire

    Once at baseline

  • Costs; e.g. pads, absence from work, loss of income assessed by questionnaire

    Once at baseline

  • The treatments given for heavy menstrual bleedings, as surgery or medication assessed by questionnaire

    Once at baseline

Study Arms (1)

Group 1

Behavioral: No drug

Interventions

No drugBEHAVIORAL

No drug intervention. The intervention is a questionnaire with quality of life and perception of menstrual bleedings. All subjects will complete both questionnaires.

Group 1

Eligibility Criteria

Age40 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects included in the SIFO (Swedish institute of market research) volontary subject pool.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Sweden

Location

MeSH Terms

Conditions

MenorrhagiaUterine Hemorrhage

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 18, 2012

Study Start

May 1, 2012

Study Completion

June 1, 2012

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

SE(1)