Validation Study for Endometriosis PRO (VALEPRO)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Validation Study to Assess Psychometric Properties of a Newly Developed Patient Reported Outcome Tool for Endometriosis|
- Endometriosis symptoms rated by the Endometriosis Symptom Diary [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Study Completion Date:||September 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Other: No drug
Patients with expected stable endometriosis management status (EMS), i.e. patients who have not planned a change in endometriosis treatment or a therapeutic surgical procedure in the next 12 weeks and have had no change in endometriosis treatment or therapeutic surgical procedure in the previous 4 weeks.lease specify as free-text; for drugs include daily dose, dosage form dosage frequency and duration (if appl. and possible for the OS/NIS).
Other: No drug
Patients with expected change in endometriosis management status (EMS), i.e. patients who have planned a change in endometriosis treatment or a therapeutic surgical procedure during the next 12 weeks or have undergone a change in endometriosis treatment or a therapeutic surgical procedure in the previous 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643122
Show 21 Study Locations
|Study Director:||Bayer Study Director||Bayer|