Validation Study for Endometriosis PRO

Completed

Conditions studied: Endometriosis

In brief

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 facts

Study ID

NCT01643122

Run by

Bayer

People needed

275

Starts

2012-08-01

Expected to finish

2013-09-01

Last updated by the study team

2014-10-13

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Jonesboro, Arkansas, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Decatur, Georgia, United States
• Study site — Champaign, Illinois, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Rochester, Minnesota, United States
• Study site — Brooklyn, New York, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — San Angelo, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Sandy City, Utah, United States
• Study site — Norfolk, Virginia, United States
• Study site — Seattle, Washington, United States
• Study site — Many Locations, Germany

Full record on ClinicalTrials.gov

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