Validation Study for Endometriosis PRO

NCT ID: NCT01643122

Last Updated: 2014-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

No drug

Intervention Type OTHER

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

No drug

Intervention Type OTHER

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.

Interventions

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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).

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Jonesboro, Arkansas, United States

Site Status

Sacramento, California, United States

Site Status

San Diego, California, United States

Site Status

San Diego, California, United States

Site Status

San Francisco, California, United States

Site Status

New Haven, Connecticut, United States

Site Status

Decatur, Georgia, United States

Site Status

Champaign, Illinois, United States

Site Status

Worcester, Massachusetts, United States

Site Status

Rochester, Minnesota, United States

Site Status

Brooklyn, New York, United States

Site Status

Greensboro, North Carolina, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Portland, Oregon, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

San Angelo, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Sandy City, Utah, United States

Site Status

Norfolk, Virginia, United States

Site Status

Seattle, Washington, United States

Site Status

Many Locations, , Germany

Site Status

Countries

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United States Germany

References

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Seitz C, Lanius V, Lippert S, Gerlinger C, Haberland C, Oehmke F, Tinneberg HR. Patterns of missing data in the use of the endometriosis symptom diary. BMC Womens Health. 2018 Jun 8;18(1):88. doi: 10.1186/s12905-018-0578-0.

Reference Type DERIVED
PMID: 29884234 (View on PubMed)

Other Identifiers

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15849

Identifier Type: -

Identifier Source: org_study_id

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