Validation Study for Endometriosis PRO

Endometriosis Clinical Trial

— VALEPRO  

Official title:

Validation Study to Assess Psychometric Properties of a Newly Developed Patient Reported Outcome Tool for Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643122
• Other study ID #: 15849
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: October 10, 2014
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA: Ethics CommitteeGermany: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometriosis

Intervention

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).
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometriosis symptoms rated by the Endometriosis Symptom Diary		Up to 24 weeks	No

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