MenorrhagiaNCT01643304
A Swedish Questionnaire Study to Investigate the Perception of Menstrual Bleedings
An observational study of Menorrhagia, run by Bayer at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 40 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menorrhagia
- What is being tested?
- No drug
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,547 participants
- Where
- 1 siteSweden
- Study dates
- May 2012to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Subjects included in the SIFO (Swedish institute of market research) volontary subject pool.
Who may be able to join
- All women 40-45 years available in the web-panel of SIFO
- Completion of the web-based questionnaire
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Swedish Cross-sectional Study With Questionnaire to Investigate Perception of Menstrual Bleeding
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.
- Conditions
- Menorrhagia
- Being tested
- No drug
- Keywords
- Menorrhagia, Heavy menstrual bleeding, Uterine Hemorrhage, Menstruation Disturbancies
- Medical subject headings
- Menorrhagia, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drugBehavioural
No drug intervention. The intervention is a questionnaire with quality of life and perception of menstrual bleedings. All subjects will complete both questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Behavioral: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of subjectively experienced heavy menstrual bleeding assessed by questionnaire
Measured: Once at baseline
Secondary outcomes (3)
Social consequences of heavy menstrual bleedings assessed by questionnaire
Measured: Once at baseline
Costs; e.g. pads, absence from work, loss of income assessed by questionnaire
Measured: Once at baseline
The treatments given for heavy menstrual bleedings, as surgery or medication assessed by questionnaire
Measured: Once at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 1,547 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643304
- Sponsor's protocol ID
- 16384
- Other IDs
- NN1223SE
- Status last verified
- Nov 2013
- First submitted
- 16 Jul 2012
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Swedish Cross-sectional Study With Questionnaire to Investigate Perception of Menstrual Bleeding
- ClinicalTrials.gov ID
- NCT01643304
- Acronym / sponsor ID
- 16384
- Conditions
- Menorrhagia
- Keywords
- Menorrhagia, Heavy menstrual bleeding, Uterine Hemorrhage, Menstruation Disturbancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,547 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: No drug |
Who may qualify
- Ages
- 40 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects included in the SIFO (Swedish institute of market research) volontary subject pool.
Key inclusion criteria (2 listed)
- All women 40-45 years available in the web-panel of SIFO
- Completion of the web-based questionnaire
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No drugNo drug intervention. The intervention is a questionnaire with quality of life and perception of menstrual bleedings. All subjects will complete both questionnaires. | Behavioural | Group 1 |
Primary outcome
Prevalence of subjectively experienced heavy menstrual bleeding assessed by questionnaire
Time frame: Once at baseline
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menorrhagia, run by Bayer at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of subjectively experienced heavy menstrual bleeding assessed by questionnaire (time frame: Once at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.