Validation Study for Endometriosis PRO (VALEPRO)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01643122

First received: July 4, 2012

Last updated: March 13, 2013

Last verified: March 2013

History of Changes

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:

MedlinePlus related topics: Endometriosis

U.S. FDA Resources

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 ]

Estimated Enrollment:	250
Study Start Date:	August 2012
Estimated Study Completion Date:	August 2013
Estimated 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

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:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT01643122 History of Changes
Other Study ID Numbers:	15849
Study First Received:	July 4, 2012
Last Updated:	March 13, 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 May 19, 2013

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