Validation Study for Endometriosis PRO
VALEPRO
Validation Study to Assess Psychometric Properties of a Newly Developed Patient Reported Outcome Tool for Endometriosis
1 other identifier
observational
275
2 countries
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
21 active sites
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
First Submitted
Initial submission to the registry
July 4, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedOctober 13, 2014
October 1, 2014
11 months
July 4, 2012
October 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endometriosis symptoms rated by the Endometriosis Symptom Diary
Up to 24 weeks
Study Arms (2)
Group 1
Group 2
Interventions
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).
Eligibility Criteria
Women with endometriosis confirmed by laparoscopy
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (21)
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
Sacramento, California, 95816, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
San Francisco, California, 94102, United States
Unknown Facility
New Haven, Connecticut, 06511, United States
Unknown Facility
Decatur, Georgia, 30034, United States
Unknown Facility
Champaign, Illinois, 61820, United States
Unknown Facility
Worcester, Massachusetts, 01655, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
Brooklyn, New York, 11203, United States
Unknown Facility
Greensboro, North Carolina, 27408, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
San Angelo, Texas, 76904, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
Sandy City, Utah, 84070, United States
Unknown Facility
Norfolk, Virginia, 23502, United States
Unknown Facility
Seattle, Washington, 98105, United States
Unknown Facility
Many Locations, Germany
Related Publications (1)
Seitz C, Lanius V, Lippert S, Gerlinger C, Haberland C, Oehmke F, Tinneberg HR. Patterns of missing data in the use of the endometriosis symptom diary. BMC Womens Health. 2018 Jun 8;18(1):88. doi: 10.1186/s12905-018-0578-0.
PMID: 29884234DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2012
First Posted
July 17, 2012
Study Start
August 1, 2012
Primary Completion
July 1, 2013
Study Completion
September 1, 2013
Last Updated
October 13, 2014
Record last verified: 2014-10