Endometriosis
Conditions
Keywords
Endometriosis, Validation study
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.
Interventions
OTHERNo 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).
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endometriosis symptoms rated by the Endometriosis Symptom Diary | Up to 24 weeks |
Countries
Germany, United States
Outcome results
None listed