Trial Condition(s):

Endometriosis

Validation Study for Endometriosis PRO (VALEPRO)

Bayer Identifier:

15849

ClinicalTrials.gov Identifier:

NCT01643122

EudraCT Number:

Not Available

Study Completed

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.

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
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Phase
N/A
Could I receive a placebo?
No
Products
No Drug
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 
Locations

SUNY Downstate Medical Center

Brooklyn, United States, 11203

Status
Completed
 
Locations

Seattle Women's: Health, Research, Gynecology

Seattle, United States, 98105

Status
Completed
 
Locations

NEA Baptist Women’s Clinic

Jonesboro, United States, 72401

Status
Completed
 
Locations

Tidewater Physicians for Women

Norfolk, United States, 23502

Status
Completed
 
Locations

Sentral Clinical Research Services

Cincinnati, United States, 45242

Status
Completed
 
Locations

Salt Lake Women's Center

Sandy, United States, 84070

Status
Completed
 
Locations

Genesis Center for Clinical Research

San Diego, United States, 92103

Status
Completed
 
Locations

Phase II Center for Women's Health

Salt Lake City, United States, 84107

Status
Terminated
 
Locations

Oregon Health and Science University

Portland, United States, 97239

Status
Completed
 
Locations

Soapstone Center for Clinical Research

Decatur, United States, 30034

Status
Completed
 
Locations

Yale University School of Medicine

New Haven, United States, 06511

Status
Terminated
 
Locations

PharmQuest, LLC

Greensboro, United States, 27408

Status
Completed
 
Locations

University of Pennsylvania

Philadelphia, United States, 19104

Status
Completed
 
Locations

Medical Center for Clinical Research

San Diego, United States, 92108

Status
Completed
 
Locations

Women's Health Practice

Champaign, United States, 61820

Status
Completed
 
Locations

Benchmark Research

Sacramento, United States, 95816

Status
Completed
 
Locations

Mayo Clinic - Rochester

Rochester, United States, 55905

Status
Completed
 
Locations

University of Massachusetts Memorial Medical Center

Worcester, United States, 01655

Status
Terminated
 
Locations

Benchmark Research

San Francisco, United States, 94102

Status
Completed
 
Locations

Benchmark Research

San Angelo, United States, 76904

Status
Completed
 

Trial Design