VALEPRO: Validation Study for Endometriosis PRO

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01643122

Collaborator

(none)

275

Enrollment

Locations

Duration (Months)

13.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Endometriosis	Other: No drug Other: No drug

Study Design

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 :

Aug 1, 2012

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Endometriosis symptoms rated by the Endometriosis Symptom Diary [Up to 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Jonesboro	Arkansas	United States	72401
2	Sacramento	California	United States	95816
3	San Diego	California	United States	92103
4	San Diego	California	United States	92108
5	San Francisco	California	United States	94102
6	New Haven	Connecticut	United States	06511
7	Decatur	Georgia	United States	30034
8	Champaign	Illinois	United States	61820
9	Worcester	Massachusetts	United States	01655
10	Rochester	Minnesota	United States	55905
11	Brooklyn	New York	United States	11203
12	Greensboro	North Carolina	United States	27408
13	Cincinnati	Ohio	United States	45242
14	Portland	Oregon	United States	97239
15	Philadelphia	Pennsylvania	United States	19104
16	San Angelo	Texas	United States	76904
17	Salt Lake City	Utah	United States	84107
18	Sandy	Utah	United States	84070
19	Norfolk	Virginia	United States	23502
20	Seattle	Washington	United States	98105
21	Many Locations		Germany

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT01643122

Other Study ID Numbers:

15849

First Posted:

Jul 17, 2012

Last Update Posted:

Oct 13, 2014

Last Verified:

Oct 1, 2014

Keywords provided by Bayer

Endometriosis, Validation study

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Oct 13, 2014