Study Completed

Endometriosis

Bayer Identifier:

15849

ClinicalTrials.gov Identifier:

NCT01643122

EudraCT Number:

Not Available

EU CT Number:

Not Available

Validation Study for Endometriosis PRO

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years

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

Trial summary

Enrollment Goal

275

Trial Dates

August 2012 - September 2013

Phase

N/A

Could I Receive a placebo

Products

No Drug

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Germany
Completed	SUNY Downstate Medical Center	Brooklyn, 11203, United States
Completed	Seattle Women's: Health, Research, Gynecology	Seattle, 98105, United States
Completed	NEA Baptist Women’s Clinic	Jonesboro, 72401, United States
Completed	Tidewater Physicians for Women	Norfolk, 23502, United States
Completed	Sentral Clinical Research Services	Cincinnati, 45242, United States
Completed	Salt Lake Women's Center	Sandy, 84070, United States
Completed	Genesis Center for Clinical Research	San Diego, 92103, United States
Terminated	Phase II Center for Women's Health	Salt Lake City, 84107, United States
Completed	Oregon Health and Science University	Portland, 97239, United States
Completed	Soapstone Center for Clinical Research	Decatur, 30034, United States
Terminated	Yale University School of Medicine	New Haven, 06511, United States
Completed	PharmQuest, LLC	Greensboro, 27408, United States
Completed	University of Pennsylvania	Philadelphia, 19104, United States
Completed	Medical Center for Clinical Research	San Diego, 92108, United States
Completed	Women's Health Practice	Champaign, 61820, United States
Completed	Benchmark Research	Sacramento, 95816, United States
Completed	Mayo Clinic - Rochester	Rochester, 55905, United States
Terminated	University of Massachusetts Memorial Medical Center	Worcester, 01655, United States
Completed	Benchmark Research	San Francisco, 94102, United States
Completed	Benchmark Research	San Angelo, 76904, United States

Primary Outcome

Endometriosis symptoms rated by the Endometriosis Symptom Diary
Time Frame:
Up to 24 weeks
Safety Issue:
No

Trial design

Validation study to assess psychometric properties of a newly developed Patient Reported Outcome tool for Endometriosis

Trial Type

Observational

Intervention Type

Other

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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