Validation Study for Endometriosis PRO



Status:Completed
Conditions:Women's Studies, Endometriosis
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:August 2012
End Date:July 2013
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayerhealthcare.com

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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.


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
We found this trial at
16
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