A Study of Women Receiving Standard of Care (SOC) for the Treatment of Pelvic Pain Due to Suspected or Confirmed Endometriosis and the Impact on the Disease or Symptom Progression.

November 16, 2021 updated by: AbbVie

A Multicenter, Observational Cohort Study of Women Receiving Standard of Care (SOC) for the Treatment of Pelvic Pain Attributable to Suspected or Confirmed Endometriosis

This study will describe historic, current, and evolving treatment pathways, treatments, and interventions in women with a suspected or confirmed diagnosis of endometriosis in order to better understand the impact of early intervention on the disease or its symptoms. Length of treatment is dependent on standard of care treatment provided and all study information will be collected during routine standard of care visits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
291

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham - Women's and Infant's Center /ID# 216236
      • Decatur, Alabama, United States, 30033
        • Atlanta VAMC /ID# 215763
      • Fairhope, Alabama, United States, 36532
        • Brown, Pearson, Guepet Gynecology /ID# 215500
      • Mobile, Alabama, United States, 36604-1410
        • Women's Health Alliance of Mobile /ID# 213719
      • Mobile, Alabama, United States, 36608
        • Mobile, Ob-Gyn, P.C. /ID# 217761
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research-Tucs /ID# 216352
    • California
      • Los Angeles, California, United States, 90036-4667
        • Olympia Clinical Trials /ID# 216238
      • Palo Alto, California, United States, 94304-1805
        • Camran Nezhat Institute /ID# 216083
      • San Diego, California, United States, 92121
        • Infertility, Gynecology & Obst /ID# 213734
      • San Diego, California, United States, 92123-3357
        • West Coast Medical Research, I /ID# 217638
    • Colorado
      • Denver, Colorado, United States, 80204-4532
        • Women's Care Clinic - Denver Health Main Campus /ID# 217975
      • Greenwood Village, Colorado, United States, 80111
        • Advanced Women's Health Institute /ID# 217342
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University /ID# 217978
      • Stamford, Connecticut, United States, 06902
        • Stamford Hospital /ID# 216975
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Health Service /ID# 218097
      • Newark, Delaware, United States, 19713
        • Reproductive Assoc of Delaware /ID# 216082
    • Florida
      • Clearwater, Florida, United States, 33759
        • Women's Medical Research Group /ID# 216230
      • Kissimmee, Florida, United States, 34741-4986
        • GYN Research Institute - Kissimmee /ID# 217979
      • Lake Worth, Florida, United States, 33461
        • Altus Research, Inc /ID# 213740
      • Margate, Florida, United States, 33063
        • South Florida Wellness & Clinic /ID# 217637
      • Miami, Florida, United States, 33136
        • University of Miami /ID# 217952
      • Miami, Florida, United States, 33186-1309
        • Palmetto Professional Research /ID# 218051
      • Orange City, Florida, United States, 32763-2833
        • A Premier Clinical Research of Florida, LLC /ID# 217949
      • Sarasota, Florida, United States, 34239
        • Physician Care Clin. Res., LLC /ID# 216570
      • Tampa, Florida, United States, 33609-4044
        • GCP Clinical Research, LLC /ID# 218861
      • Tampa, Florida, United States, 33612
        • University of South Florida /ID# 217606
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials /ID# 217595
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Journey Medical Research Insti /ID# 216077
      • Atlanta, Georgia, United States, 30328-5532
        • Agile Clinical Research Trials /ID# 217762
      • Atlanta, Georgia, United States, 30328
        • Academia Women's Health /ID# 218075
      • Atlanta, Georgia, United States, 30342-1731
        • Emory Saint Joseph's Hospital /ID# 213746
      • Atlanta, Georgia, United States, 30342
        • Atlanta Women's Research Inst /ID# 216571
      • Atlanta, Georgia, United States, 30363
        • Medisense Inc /ID# 218342
      • Augusta, Georgia, United States, 30909-6484
        • Augusta OB/GYN Specialists LLC /ID# 218076
      • College Park, Georgia, United States, 30349-3103
        • Paramount Research Solutions - College Park /ID# 217959
      • Marietta, Georgia, United States, 30060-1134
        • WellStar Kennestone Women's Health Clinic /ID# 216983
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-8322
        • Leavitt Womens Healthcare /ID# 221355
      • Idaho Falls, Idaho, United States, 83404
        • Womens Healthcare Assoc, DBA /ID# 217839
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research /ID# 218346
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Women's Health Practice, LLC /ID# 216964
      • Chicago, Illinois, United States, 60611-2987
        • Northwestern Medicine Fertility and Reproductive Medicine /ID# 217662
      • Oak Brook, Illinois, United States, 60523
        • Affinity Clinical Research /ID# 218203
      • Park Ridge, Illinois, United States, 60068
        • The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 217635
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Women's Health Advantage /ID# 217951
    • Iowa
      • Waterloo, Iowa, United States, 50703-1901
        • UnityPoint Clinic OB/GYN - Waterloo /ID# 216087
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Univ Kansas Med Ctr /ID# 216086
      • Shawnee Mission, Kansas, United States, 66218
        • Womens & Family Care, LLC dba /ID# 216569
      • Wichita, Kansas, United States, 67226
        • Cypress Medical Research Ctr /ID# 218054
    • Kentucky
      • Louisville, Kentucky, United States, 40207-4700
        • Norton Children's Gynecology /ID# 215671
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Horizon Research Group /ID# 217337
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Baptist Medical Centre /ID# 215762
      • Shreveport, Louisiana, United States, 71103
        • LSUHSC - Shreveport /ID# 216229
      • Shreveport, Louisiana, United States, 71118
        • Omni Fertility and Laser Insti /ID# 217764
    • Maine
      • Augusta, Maine, United States, 04330-8160
        • MaineGeneral Obstetrics & Gynecology /ID# 217634
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Med Ctr /ID# 216080
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University /ID# 217958
      • Glen Burnie, Maryland, United States, 21063
        • Womens Health Center /ID# 216235
      • Hagerstown, Maryland, United States, 21740-6555
        • Capital Women's Care - Hagerstown /ID# 217984
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center /ID# 218344
      • Brockton, Massachusetts, United States, 02301-1168
        • Hanjani PC /ID# 217953
      • Cambridge, Massachusetts, United States, 02138-1040
        • Boston Urogynecology Associates /ID# 216232
      • Fall River, Massachusetts, United States, 02720-2972
        • NECCR Fall River LLC /ID# 216079
      • Worcester, Massachusetts, United States, 01605-2903
        • UMass Memorial Health Care /ID# 217608
    • Michigan
      • Bay City, Michigan, United States, 48602
        • Great Lakes Research, Inc. /ID# 215764
      • Saginaw, Michigan, United States, 48602-5303
        • Central Michigan University Health /ID# 216237
      • Saginaw, Michigan, United States, 48604
        • Saginaw Valley Med Res Group /ID# 217763
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medi /ID# 217636
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University School of Medicine /ID# 217633
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • CHI Health /ID# 216074
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • R. Garn Mabey Jr, MD Chartered /ID# 218065
    • New Jersey
      • Marlton, New Jersey, United States, 08053-3464
        • Cooper University Hospital/Sheridan Pavilion /ID# 218066
      • Neptune, New Jersey, United States, 07753-4859
        • Jersey Shore University Medical Center /ID# 216488
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson /ID# 216972
    • New York
      • Buffalo, New York, United States, 14202
        • Circuit Clinical - Buffalo /ID# 217656
      • East Syracuse, New York, United States, 13057-3072
        • Widewaters Gynecology /ID# 217661
      • New York, New York, United States, 10016-6023
        • Manhattan Medical Research /ID# 217950
      • New York, New York, United States, 10029-6501
        • Mount Sinai Medical Center - NY /ID# 216208
      • Port Jefferson, New York, United States, 11777
        • Suffolk Obstetrics and Gyneco /ID# 213781
      • Staten Island, New York, United States, 10306
        • Richmond OB/GYN Associates PC /ID# 217642
      • Staten Island, New York, United States, 10309-2622
        • Island Reproductive Services - Staten Island /ID# 218202
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University - Downtown /ID# 217596
    • North Carolina
      • Asheville, North Carolina, United States, 28803-2868
        • MAHEC OB/GYN Specialists /ID# 216973
      • Durham, North Carolina, United States, 27713
        • Carolina Women's Research and Wellness Center /ID# 216962
      • Hillsborough, North Carolina, United States, 27278-9078
        • UNC Hospitals - Hillsborough /ID# 218343
      • New Bern, North Carolina, United States, 28562
        • Eastern Carolina Women's Centr /ID# 217335
      • Raleigh, North Carolina, United States, 27612-8106
        • M3 Wake Research Inc. /ID# 217167
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0457
        • Univ of Cincinnati Physicians /ID# 217643
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland /ID# 216075
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center /ID# 217169
      • Columbus, Ohio, United States, 43213
        • Aventiv Research, Inc. /ID# 221293
      • Columbus, Ohio, United States, 43231
        • Complete Healthcare for Women /ID# 216961
      • Dayton, Ohio, United States, 45324
        • Wright State Univ, School Med /ID# 216084
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001-3714
        • Abington Reproductive Medicine /ID# 216575
      • Hershey, Pennsylvania, United States, 17033-2360
        • Penn State University and Milton S. Hershey Medical Center /ID# 213787
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Vista Clinical Research /ID# 213789
      • Greenville, South Carolina, United States, 29605
        • University Medical Group /ID# 217954
      • Myrtle Beach, South Carolina, United States, 29572
        • Venus Gynecology, LLC /ID# 213790
      • Summerville, South Carolina, United States, 29485-7539
        • Palmetto Clinical Research /ID# 216076
      • Summerville, South Carolina, United States, 29485-8154
        • Women's Health Partners - Summerville /ID# 217339
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Chattanoogas Program in Womens /ID# 218052
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research /ID# 217594
      • Nashville, Tennessee, United States, 37203-2012
        • Paramount Research Solutions - Nashville /ID# 217341
      • Nashville, Tennessee, United States, 37209-4035
        • Urology Associates PC - Nashville /ID# 218139
    • Texas
      • Dallas, Texas, United States, 75203-1201
        • Methodist Dallas Medical Center /ID# 218350
      • Denton, Texas, United States, 76210
        • The Women's Centre /ID# 213794
      • Fort Worth, Texas, United States, 76104
        • Signature Gyn Services /ID# 216354
      • Frisco, Texas, United States, 75035
        • Willowbend Health and Wellness - Frisco /ID# 217601
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital /ID# 216967
      • San Antonio, Texas, United States, 78229
        • Univ Texas HSC San Antonio /ID# 218070
    • Utah
      • Draper, Utah, United States, 84020
        • Physicians Research Options, L /ID# 213799
      • Riverton, Utah, United States, 84065
        • Granger Medical Clin-Riverton /ID# 218086
    • Virginia
      • Leesburg, Virginia, United States, 20176-3465
        • Virginia Obstetrics & Gynecology /ID# 215797
      • Reston, Virginia, United States, 20190-3215
        • Virginia Women's Health Associates - Reston /ID# 217990
      • Richmond, Virginia, United States, 23220-4459
        • Clinical Research Partners, LLC /ID# 216355
      • Vienna, Virginia, United States, 22182-2665
        • The Chronic Pelvic Pain Center of Northern VA /ID# 217630
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Reproductive Medicine /ID# 213801
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University /ID# 217664

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This study will enroll women of reproductive age (between first onset of menses and before onset of menopause) with a suspected or confirmed diagnosis of endometriosis.

Description

Inclusion Criteria:

  • Women of reproductive age (between their first menstrual cycle and before onset of menopause).
  • Women who have experienced chronic pelvic pain (CPP) and/or dysmenorrhea (DYS) for at least 6 months prior to enrollment without symptom improvement with non-steroidal anti-inflammatory drugs (NSAIDs) or hormone/medical treatment.
  • Women with suspected or confirmed endometriosis (EM) at time of enrollment.
  • Women with CPP and/or DYS impacting daily activities as determined by their treating physician.
  • Able to read, understand and respond to patient questionnaires.
  • Willing to sign a patient authorization and/or informed consent form (ICF) and agree to disclose personal health information.

NOTE: For pediatric patients, parental/guardian assent/ICF is also required.

Exclusion Criteria:

  • Women with chronic pelvic pain (CPP) and/or dysmenorrhea(DYS) for reasons other than endometriosis (EM).
  • Women who have had a hysterectomy and/or bilateral ovary removal (oophorectomy).
  • Women who are pregnant or planning to become pregnant.
  • Women currently using assisted reproductive technologies such as in vitro fertilization (IVF).
  • Women with a history of, or current malignancy (with or without systemic chemotherapy) with the exception of basal cell carcinoma of the skin.
  • Women who are currently participating in an interventional clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Women with suspected or confirmed endometriosis
Women with suspected or confirmed endometriosis undergoing standard of care treatments or interventions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants using specific medications for the treatment of chronic pelvic pain (CPP) and/or dysmenorrhea (DYS)
Time Frame: From onset of CPP and/or DYS to up to 4 years following study enrollment.
Data regarding medication use for CPP and/or DYS will be collected from participant medical records, health care provider questionnaires, and participant completed questionnaires.
From onset of CPP and/or DYS to up to 4 years following study enrollment.
Percentage of participants who underwent surgical interventions for the treatment of CPP and/or DYS
Time Frame: From onset of CPP and/or DYS to up to 4 years following study enrollment.
Percentage of participants who underwent surgical interventions for the treatment of CPP and/or DYS at any point from onset of CPP and/or DYS and study completion.
From onset of CPP and/or DYS to up to 4 years following study enrollment.
Number of surgical interventions for the treatment of CPP and/or DYS
Time Frame: From onset of CPP and/or DYS to up to 4 years following study enrollment.
Number of surgical interventions for the treatment of CPP and/or DYS.
From onset of CPP and/or DYS to up to 4 years following study enrollment.
Percentage of participants undergoing hysterectomy
Time Frame: From study enrollment (Week 0) to up to 4 years.
Percentage of participants undergoing hysterectomy during study enrollment.
From study enrollment (Week 0) to up to 4 years.
Percentage of participants undergoing infertility treatment
Time Frame: From study enrollment (Week 0) to up to 4 years.
Percentage of participants undergoing infertility treatments during study enrollment.
From study enrollment (Week 0) to up to 4 years.
Percentage of participants undergoing surgery
Time Frame: From study enrollment (Week 0) to up to 4 years.
Percentage of participants undergoing surgery as treatment for CPP and/or DYS.
From study enrollment (Week 0) to up to 4 years.
Percentage of participants with complications associated with surgery
Time Frame: From study enrollment (Week 0) to up to 4 years.
Percentage of participants with complications associated with surgery.
From study enrollment (Week 0) to up to 4 years.
Percentage of participants receiving specific treatment sequences for the treatment of CPP and/or DYS
Time Frame: From onset of CPP and/or DYS to up to 4 years following study enrollment.
Treatment sequences will be identified from the data. Treatment switching, add-on treatment, and discontinuations (including reasons) will be collected wherever possible.
From onset of CPP and/or DYS to up to 4 years following study enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 19, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P16-836

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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