Validation Study for Endometriosis PRO (VALEPRO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01643122
First received: July 4, 2012
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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.


Condition
Endometriosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation Study to Assess Psychometric Properties of a Newly Developed Patient Reported Outcome Tool for Endometriosis

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Endometriosis symptoms rated by the Endometriosis Symptom Diary [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 275
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Group 2

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with endometriosis confirmed by laparoscopy

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643122

  Show 21 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01643122     History of Changes
Other Study ID Numbers: 15849
Study First Received: July 4, 2012
Last Updated: October 14, 2013
Health Authority: USA: Ethics Committee
Germany: Ethics Committee

Keywords provided by Bayer:
Endometriosis, Validation study

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014