Validation Study for Endometriosis PRO (VALEPRO)

Bayer

Status: Completed

Conditions: Endometriosis

Treatments: Other: No drug

Study type: Observational

Funder types: Industry

Identifiers

NCT01643122

15849

Details and patient eligibility

About

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.

Enrollment: 275 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

275 participants in 2 patient groups

Group 1

Treatment:

Other: No drug

Other: No drug

Group 2

Treatment:

Other: No drug

Other: No drug