NCT02001324

Brief Summary

This is an observational study to determine the effect of various treatments prescribed by healthcare providers for heavy menstrual bleeding on bleeding related quality of life (as measured by the Menstrual Bleeding Questionnaire) and to compare electronic and paper-based modes of data collection.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

November 27, 2013

Last Update Submit

August 23, 2021

Conditions

Heavy Menstrual Bleeding

Keywords

quality of lifeheavy menstrual bleedingelectronic data collection

Outcome Measures

Primary Outcomes (1)

  • Menstrual bleeding questionnaire score

    Condition-specific quality of life measurement tool for heavy menstrual bleeding compare change in quality of life over time between women receiving different treatments for heavy menstrual bleeding

    6 months

Secondary Outcomes (1)

  • Quality of data collected

    6 Months

Study Arms (2)

Paper-based data collection

ACTIVE COMPARATOR

Paper-based data collection

Other: Paper-based data collection

Web-based data collection

ACTIVE COMPARATOR

Web-based data collection

Other: Web-based data collection

Interventions

Web-based data collectionOTHER
Web-based data collection
Paper-based data collectionOTHER
Paper-based data collection

Eligibility Criteria

Age18 Years - 51 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who are presenting for gynecologic visits or well-woman examinations who still have an intact uterus and are between the ages of 18 and 51 years, have abnormal uterine bleeding, and can read and write in English.

You may not qualify if:

  • Women who are presently on a treatment for abnormal uterine bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

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

  • Kristen Matteson, MD, MPH

    Women & Infants Hospital, Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 4, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2015

Study Completion

December 31, 2018

Last Updated

August 24, 2021

Record last verified: 2021-08

Locations

US(1)