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Validation Study for Endometriosis PRO (VALEPRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01643122
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Endometriosis Other: No drug

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Study Type : Observational
Actual Enrollment : 275 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation Study to Assess Psychometric Properties of a Newly Developed Patient Reported Outcome Tool for Endometriosis
Study Start Date : August 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort Intervention/treatment
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 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).

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.




Primary Outcome Measures :
  1. Endometriosis symptoms rated by the Endometriosis Symptom Diary [ Time Frame: Up to 24 weeks ]


Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643122


Locations
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United States, Arkansas
Jonesboro, Arkansas, United States, 72401
United States, California
Sacramento, California, United States, 95816
San Diego, California, United States, 92103
San Diego, California, United States, 92108
San Francisco, California, United States, 94102
United States, Connecticut
New Haven, Connecticut, United States, 06511
United States, Georgia
Decatur, Georgia, United States, 30034
United States, Illinois
Champaign, Illinois, United States, 61820
United States, Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New York
Brooklyn, New York, United States, 11203
United States, North Carolina
Greensboro, North Carolina, United States, 27408
United States, Ohio
Cincinnati, Ohio, United States, 45242
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
San Angelo, Texas, United States, 76904
United States, Utah
Salt Lake City, Utah, United States, 84107
Sandy, Utah, United States, 84070
United States, Virginia
Norfolk, Virginia, United States, 23502
United States, Washington
Seattle, Washington, United States, 98105
Germany
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01643122    
Other Study ID Numbers: 15849
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014
Keywords provided by Bayer:
Endometriosis, Validation study
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female