Validation Study for Endometriosis PRO

Completed

• Conditions: Endometriosis
• Interventions: Other: No drug

• Registration Number: NCT01643122
• Lead Sponsor: Bayer

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 Description

Not available

Study Timeline

• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Study Start: 2012-08
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-10
• Last Update Posted: 2014-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 275

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)

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	No drug	-
Group 2	No drug	-

Primary Outcome Measures

Name	Time	Method
Endometriosis symptoms rated by the Endometriosis Symptom Diary	Up to 24 weeks