check_circleStudy Completed

Endometriosis

Bayer Identifier:

15849

ClinicalTrials.gov Identifier:

NCT01643122

EudraCT Number:

Not Available

EU CT Number:

Not Available
Validation Study for Endometriosis PRO

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - 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)
  • - 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

Trial summary

Enrollment Goal
275
Trial Dates
August 2012 - September 2013
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany
Completed
SUNY Downstate Medical CenterBrooklyn, 11203, United States
Completed
Seattle Women's: Health, Research, GynecologySeattle, 98105, United States
Completed
NEA Baptist Women’s ClinicJonesboro, 72401, United States
Completed
Tidewater Physicians for WomenNorfolk, 23502, United States
Completed
Sentral Clinical Research ServicesCincinnati, 45242, United States
Completed
Salt Lake Women's CenterSandy, 84070, United States
Completed
Genesis Center for Clinical ResearchSan Diego, 92103, United States
Terminated
Phase II Center for Women's HealthSalt Lake City, 84107, United States
Completed
Oregon Health and Science UniversityPortland, 97239, United States
Completed
Soapstone Center for Clinical ResearchDecatur, 30034, United States
Terminated
Yale University School of MedicineNew Haven, 06511, United States
Completed
PharmQuest, LLCGreensboro, 27408, United States
Completed
University of PennsylvaniaPhiladelphia, 19104, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
Women's Health PracticeChampaign, 61820, United States
Completed
Benchmark ResearchSacramento, 95816, United States
Completed
Mayo Clinic - RochesterRochester, 55905, United States
Terminated
University of Massachusetts Memorial Medical CenterWorcester, 01655, United States
Completed
Benchmark ResearchSan Francisco, 94102, United States
Completed
Benchmark ResearchSan Angelo, 76904, United States

Primary Outcome

  • Endometriosis symptoms rated by the Endometriosis Symptom Diary
    date_rangeTime Frame:
    Up to 24 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

Validation study to assess psychometric properties of a newly developed Patient Reported Outcome tool for Endometriosis
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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