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Validation Study for Endometriosis PRO (VALEPRO)

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: July 4, 2012
Last updated: October 10, 2014
Last verified: October 2014
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 Intervention
Other: No drug

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 ]

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 Assigned Interventions
Group 1 Other: No 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 specify as free-text; for drugs include daily dose, dosage form dosage frequency and duration (if appl. and possible for the OS/NIS).
Group 2 Other: No drug
Patients with expected change in endometriosis management status (EMS), i.e. patients who have planned a change in endometriosis treatment or a therapeutic surgical procedure during the next 12 weeks or have undergone a change in endometriosis treatment or a therapeutic surgical procedure in the previous 4 weeks.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with endometriosis confirmed by laparoscopy

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 identifier: NCT01643122

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

Additional Information:
Responsible Party: Bayer Identifier: NCT01643122     History of Changes
Other Study ID Numbers: 15849
Study First Received: July 4, 2012
Last Updated: October 10, 2014

Keywords provided by Bayer:
Endometriosis, Validation study

Additional relevant MeSH terms:
Genital Diseases, Female processed this record on May 22, 2017