MenorrhagiaNCT02304510
Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing
An observational study of Menorrhagia, run by Peking University at 1 site in China.
Trial summary
The purpose of the study is to estimate the prevalence of heavy menstrual bleeding (HMB) in females aged between 18 and 50 years old living in Bejing. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Menorrhagia
- How many people
- 2,455 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Dec 2016
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: residents of Beijing
Who may be able to join
- Females aged between 18 and 50 years (inclusive)
- Stay in Beijing for more than 6 months
- Signed ICF was obtained
Who cannot join
- Not achieve the menarche
- With the last menstruation more than one year ago
- Experienced amenorrhea, currently take hormone therapy to induce menstruation
- Had undergone a hysterectomy
- Currently breastfeeding a baby
- Being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to estimate the prevalence of heavy menstrual bleeding (HMB) in females aged between 18 and 50 years old living in Bejing.
Read the detailed description
This study is an observational, cross-sectional study. A representative sample of 2800 eligible women with different occupations such as farmers, service providers, workers, professional specialists, students and civil servants will be recruited. A cluster sampling method with probability proportional to the distribution of occupation in women in Beijing will be used. Demographic data will be collected by questionnaire. Menstrual bleeding will be evaluated by Pictorial Blood loss Assessment Chart (PBAC). According to the international definition of HMB, a PBAC score more than 100 is considered as HMB.
- Conditions
- Menorrhagia
- Keywords
- Prevalence, Menorrhagia
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| females | females aged between 18 and 50 years old living in Beijing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HMB
Measured: from date of inclusion until the end of the study currently planned (about 7 months)
Secondary outcomes (2)
Prevalence of HMB in different subgroups
Subgroups include groups with different age, occupations, education levels, fertility status, with/without combined gynecological diseases.
Measured: from date of inclusion until the end of the study currently planned (about 7 months)
Identify risk factors associated with HMB
Identified HMB subjects will be assigned into the case group. Non-HMB subjects will be assigned into the control group. Logistic regression model will be carried out to analyze the associations between possible demographic factors and risk of HMB by calculating odds ratios (OR) with 95% confidence intervals (CIs).
Measured: from date of inclusion until the end of the study currently planned (about 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionSep 2015
- Study completionDec 2016
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 Peking UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Siyan Zhan, Peking University
- Investigators
- Siyan Zhan, MD,PhD, Principal investigator, Peking University Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304510
- Sponsor's protocol ID
- PEKU-BJ-2014
- Status last verified
- Dec 2018
- First submitted
- 27 Nov 2014
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing
- ClinicalTrials.gov ID
- NCT02304510
- Acronym / sponsor ID
- PEKU-BJ-2014
- Conditions
- Menorrhagia
- Keywords
- Prevalence, Menorrhagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,455 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Nov 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Dec 2014 (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.
The purpose of the study is to estimate the prevalence of heavy menstrual bleeding (HMB) in females aged between 18 and 50 years old living in Bejing.
Detailed description
This study is an observational, cross-sectional study. A representative sample of 2800 eligible women with different occupations such as farmers, service providers, workers, professional specialists, students and civil servants will be recruited. A cluster sampling method with probability proportional to the distribution of occupation in women in Beijing will be used. Demographic data will be collected by questionnaire. Menstrual bleeding will be evaluated by Pictorial Blood loss Assessment Chart (PBAC). According to the international definition of HMB, a PBAC score more than 100 is considered as HMB.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| females | – | –females aged between 18 and 50 years old living in Beijing |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- residents of Beijing
Key inclusion criteria (3 listed)
- Females aged between 18 and 50 years (inclusive)
- Stay in Beijing for more than 6 months
- Signed ICF was obtained
Key exclusion criteria (6 listed)
- Not achieve the menarche
- With the last menstruation more than one year ago
- Experienced amenorrhea, currently take hormone therapy to induce menstruation
- Had undergone a hysterectomy
- Currently breastfeeding a baby
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of HMB
Time frame: from date of inclusion until the end of the study currently planned (about 7 months)
2 secondary outcomes
Prevalence of HMB in different subgroups
Time frame: from date of inclusion until the end of the study currently planned (about 7 months)
Identify risk factors associated with HMB
Time frame: from date of inclusion until the end of the study currently planned (about 7 months)
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 31 Dec 2018.
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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.
Siyan Zhan, MD,PhD principal investigator
Peking University Health Science Center
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 Peking University at 1 site in China.
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 3 inclusion and 6 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 31 Dec 2018. 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 China. 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 HMB (time frame: from date of inclusion until the end of the study currently planned (about 7 months)). 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 31 Dec 2018.