Trial Condition(s):
Validation Study for Endometriosis PRO (VALEPRO)
15849
Not Available
Not Available
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.
- 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
Locations | |
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Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SUNY Downstate Medical Center Brooklyn, United States, 11203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seattle Women's: Health, Research, Gynecology Seattle, United States, 98105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NEA Baptist Women’s Clinic Jonesboro, United States, 72401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tidewater Physicians for Women Norfolk, United States, 23502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sentral Clinical Research Services Cincinnati, United States, 45242 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Salt Lake Women's Center Sandy, United States, 84070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genesis Center for Clinical Research San Diego, United States, 92103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Phase II Center for Women's Health Salt Lake City, United States, 84107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oregon Health and Science University Portland, United States, 97239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Soapstone Center for Clinical Research Decatur, United States, 30034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yale University School of Medicine New Haven, United States, 06511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PharmQuest, LLC Greensboro, United States, 27408 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Pennsylvania Philadelphia, United States, 19104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Women's Health Practice Champaign, United States, 61820 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Benchmark Research Sacramento, United States, 95816 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mayo Clinic - Rochester Rochester, United States, 55905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Massachusetts Memorial Medical Center Worcester, United States, 01655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Benchmark Research San Francisco, United States, 94102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Benchmark Research San Angelo, United States, 76904 | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
2