Validation Study for Endometriosis PRO

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No drug

Other

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).

Primary outcomes

Endometriosis symptoms rated by the Endometriosis Symptom Diary

Time frame: Up to 24 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: VALEPRO

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jul 17, 2012
Registry last updated: Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed