Validation Study for Endometriosis PRO (VALEPRO)
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|ClinicalTrials.gov Identifier: NCT01643122|
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : October 13, 2014
|Condition or disease||Intervention/treatment|
|Endometriosis||Other: No drug|
|Study Type :||Observational|
|Actual Enrollment :||275 participants|
|Official Title:||Validation Study to Assess Psychometric Properties of a Newly Developed Patient Reported Outcome Tool for Endometriosis|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||September 2013|
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.
- Endometriosis symptoms rated by the Endometriosis Symptom Diary [ Time Frame: Up to 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643122
Show 21 Study Locations
|Study Director:||Bayer Study Director||Bayer|