Validation Study for Endometriosis PRO (VALEPRO)

October 10, 2014 updated by: Bayer

Validation Study to Assess Psychometric Properties of a Newly Developed Patient Reported Outcome Tool for Endometriosis

Assess the psychometric properties of the Endometriosis Symptom Diary (ESD) and the Endometriosis Impact Scale (EIS) and provide evidence whether the PRO measures are reliable, valid and able to detect changes over time in approximately 250 patients with mild, moderate or severe endometriosis confirmed by laparoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Many Locations, Germany
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
    • California
      • Sacramento, California, United States, 95816
      • San Diego, California, United States, 92103
      • San Diego, California, United States, 92108
      • San Francisco, California, United States, 94102
    • Connecticut
      • New Haven, Connecticut, United States, 06511
    • Georgia
      • Decatur, Georgia, United States, 30034
    • Illinois
      • Champaign, Illinois, United States, 61820
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New York
      • Brooklyn, New York, United States, 11203
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
    • Ohio
      • Cincinnati, Ohio, United States, 45242
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • San Angelo, Texas, United States, 76904
    • Utah
      • Salt Lake City, Utah, United States, 84107
      • Sandy, Utah, United States, 84070
    • Virginia
      • Norfolk, Virginia, United States, 23502
    • Washington
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with endometriosis confirmed by laparoscopy

Description

Inclusion Criteria:

  • Women with endometriosis confirmed by laparoscopy or laparotomy within five years before the baseline visit
  • Good general health (except for findings related to endometriosis) as proven by medical history
  • Patient has experienced endometriosis symptoms (i.e. pain) in the past 4 weeks, as assessed by a numerical rating scale (NRS)

Exclusion Criteria:

  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Undiagnosed abnormal genital bleeding
  • Abuse of alcohol, drugs, or medicine (e.g., laxatives)
  • Simultaneous participation in another clinical trial. Participation in another clinical trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator.
  • Major surgery scheduled for the study period, except therapeutic surgical procedure for endometriosis
  • Close affiliation with the study site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of study site)
  • Inability to cooperate with the study procedures for any reason, including the following examples: language comprehension, psychiatric illness, inability to get to the study site
  • Previous enrollment to this study
  • Regular use of pain medication due to other underlying diseases
  • Known pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Other: No drug
Patients with expected stable endometriosis management status (EMS), i.e. patients who have not planned a change in endometriosis treatment or a therapeutic surgical procedure in the next 12 weeks and have had no change in endometriosis treatment or therapeutic surgical procedure in the previous 4 weeks.lease specify as free-text; for drugs include daily dose, dosage form dosage frequency and duration (if appl. and possible for the OS/NIS).
Other: No drug
Patients with expected change in endometriosis management status (EMS), i.e. patients who have planned a change in endometriosis treatment or a therapeutic surgical procedure during the next 12 weeks or have undergone a change in endometriosis treatment or a therapeutic surgical procedure in the previous 4 weeks.
Group 2
Other: No drug
Patients with expected stable endometriosis management status (EMS), i.e. patients who have not planned a change in endometriosis treatment or a therapeutic surgical procedure in the next 12 weeks and have had no change in endometriosis treatment or therapeutic surgical procedure in the previous 4 weeks.lease specify as free-text; for drugs include daily dose, dosage form dosage frequency and duration (if appl. and possible for the OS/NIS).
Other: No drug
Patients with expected change in endometriosis management status (EMS), i.e. patients who have planned a change in endometriosis treatment or a therapeutic surgical procedure during the next 12 weeks or have undergone a change in endometriosis treatment or a therapeutic surgical procedure in the previous 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endometriosis symptoms rated by the Endometriosis Symptom Diary
Time Frame: Up to 24 weeks
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

July 4, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (ESTIMATE)

July 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 13, 2014

Last Update Submitted That Met QC Criteria

October 10, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15849

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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