Clinical trial NCT01643122: Validation Study for Endometriosis PRO
Official title: Validation Study to Assess Psychometric Properties of a Newly Developed Patient Reported Outcome Tool for Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Endometriosis, Validation study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-07-17
Enrollment: 275
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with endometriosis confirmed by laparoscopy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Endometriosis symptoms rated by the Endometriosis Symptom Diary
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jonesboro
country: United States
state: Arkansas
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Decatur
country: United States
state: Georgia
city: Champaign
country: United States
state: Illinois
city: Worcester
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: Brooklyn
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: San Angelo
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Sandy
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Seitz C, Lanius V, Lippert S, Gerlinger C, Haberland C, Oehmke F, Tinneberg HR. Patterns of missing data in the use of the endometriosis symptom diary. BMC Womens Health. 2018 Jun 8;18(1):88. doi: 10.1186/s12905-018-0578-0.