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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02304510
Other study ID # PEKU-BJ-2014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2014
Est. completion date December 2016

Study information

Verified date December 2018
Source Peking University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2455
Est. completion date December 2016
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Females aged between 18 and 50 years (inclusive)

- Stay in Beijing for more than 6 months

- Signed ICF was obtained

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Peking University Health Science Center Beijing

Sponsors (2)

Lead Sponsor Collaborator
Peking University Bayer

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of HMB from date of inclusion until the end of the study currently planned (about 7 months)
Secondary Prevalence of HMB in different subgroups Subgroups include groups with different age, occupations, education levels, fertility status, with/without combined gynecological diseases. from date of inclusion until the end of the study currently planned (about 7 months)
Secondary 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). from date of inclusion until the end of the study currently planned (about 7 months)
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