Clinical Trial: Validation Study for Endometriosis PRO
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Validation Study to Assess Psychometric Properties of a Newly Developed Patient Reported Outcome Tool for Endometriosis
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.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: Endometriosis symptoms rated by the Endometriosis Symptom Diary [ Time Frame: Up to 24 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Bayer
Dates:
Date Received: July 4, 2012
Date Started: August 2012
Date Completion:
Last Updated: October 10, 2014
Last Verified: October 2014