NCT02304510

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Typical duration 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

November 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 31, 2018

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

November 27, 2014

Last Update Submit

December 28, 2018

Conditions

Menorrhagia

Keywords

PrevalenceMenorrhagia

Outcome Measures

Primary Outcomes (1)

  • Prevalence of HMB

    from date of inclusion until the end of the study currently planned (about 7 months)

Secondary Outcomes (2)

  • Prevalence of HMB in different subgroups

    from date of inclusion until the end of the study currently planned (about 7 months)

  • Identify risk factors associated with HMB

    from date of inclusion until the end of the study currently planned (about 7 months)

Study Arms (1)

females

females aged between 18 and 50 years old living in Beijing

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

residents of Beijing

You may qualify if:

  • Females aged between 18 and 50 years (inclusive)
  • Stay in Beijing for more than 6 months
  • Signed ICF was obtained

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Health Science Center

Beijing, 100191, China

Location

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Siyan Zhan, MD,PhD

    Peking University Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 2, 2014

Study Start

November 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2016

Last Updated

December 31, 2018

Record last verified: 2018-12

Locations

CN(1)