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EndometriosisNCT04140175

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.

An observational study of Endometriosis and Chronic Pelvic Pain, run by AbbVie at 117 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older, women only
Conditions the study is for
Endometriosis, Chronic Pelvic Pain, Dysmenorrhea
How many people
291 participants
Where
117 sitesUnited States
Study dates
20 Jan 2020to 19 Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

117 sites in 1 country.

117 sites in 1 country

United States117 sites

  • Abington Reproductive Medicine /ID# 216575

    Abington, Pennsylvania, 19001-3714

  • Journey Medical Research Insti /ID# 216077

    Alpharetta, Georgia, 30005

  • MAHEC OB/GYN Specialists /ID# 216973

    Asheville, North Carolina, 28803-2868

  • Agile Clinical Research Trials /ID# 217762

    Atlanta, Georgia, 30328-5532

  • Academia Women's Health /ID# 218075

    Atlanta, Georgia, 30328

  • Emory Saint Joseph's Hospital /ID# 213746

    Atlanta, Georgia, 30342-1731

  • Atlanta Women's Research Inst /ID# 216571

    Atlanta, Georgia, 30342

  • Medisense Inc /ID# 218342

    Atlanta, Georgia, 30363

  • Augusta OB/GYN Specialists LLC /ID# 218076

    Augusta, Georgia, 30909-6484

  • MaineGeneral Obstetrics & Gynecology /ID# 217634

    Augusta, Maine, 04330-8160

  • University of Maryland Med Ctr /ID# 216080

    Baltimore, Maryland, 21201

  • Johns Hopkins University /ID# 217958

    Baltimore, Maryland, 21287

  • Great Lakes Research, Inc. /ID# 215764

    Bay City, Michigan, 48602

  • University of Alabama at Birmingham - Women's and Infant's Center /ID# 216236

    Birmingham, Alabama, 35294

  • Boston Medical Center /ID# 218344

    Boston, Massachusetts, 02118

  • Hanjani PC /ID# 217953

    Brockton, Massachusetts, 02301-1168

  • Circuit Clinical - Buffalo /ID# 217656

    Buffalo, New York, 14202

  • Boston Urogynecology Associates /ID# 216232

    Cambridge, Massachusetts, 02138-1040

  • Women's Health Practice, LLC /ID# 216964

    Champaign, Illinois, 61820

  • Chattanoogas Program in Womens /ID# 218052

    Chattanooga, Tennessee, 37403

  • Chattanooga Medical Research /ID# 217594

    Chattanooga, Tennessee, 37404

  • Northwestern Medicine Fertility and Reproductive Medicine /ID# 217662

    Chicago, Illinois, 60611-2987

  • Univ of Cincinnati Physicians /ID# 217643

    Cincinnati, Ohio, 45267-0457

  • Women's Medical Research Group /ID# 216230

    Clearwater, Florida, 33759

  • University Hospitals Cleveland /ID# 216075

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center /ID# 217169

    Cleveland, Ohio, 44109

  • Paramount Research Solutions - College Park /ID# 217959

    College Park, Georgia, 30349-3103

  • Vista Clinical Research /ID# 213789

    Columbia, South Carolina, 29201

  • Aventiv Research, Inc. /ID# 221293

    Columbus, Ohio, 43213

  • Complete Healthcare for Women /ID# 216961

    Columbus, Ohio, 43231

  • Methodist Dallas Medical Center /ID# 218350

    Dallas, Texas, 75203-1201

  • Wright State Univ, School Med /ID# 216084

    Dayton, Ohio, 45324

  • Atlanta VAMC /ID# 215763

    Decatur, Alabama, 30033

  • The Women's Centre /ID# 213794

    Denton, Texas, 76210

  • Women's Care Clinic - Denver Health Main Campus /ID# 217975

    Denver, Colorado, 80204-4532

  • Physicians Research Options, L /ID# 213799

    Draper, Utah, 84020

  • Carolina Women's Research and Wellness Center /ID# 216962

    Durham, North Carolina, 27713

  • Widewaters Gynecology /ID# 217661

    East Syracuse, New York, 13057-3072

  • Horizon Research Group /ID# 217337

    Eunice, Louisiana, 70535

  • Brown, Pearson, Guepet Gynecology /ID# 215500

    Fairhope, Alabama, 36532

  • NECCR Fall River LLC /ID# 216079

    Fall River, Massachusetts, 02720-2972

  • Women's Health Advantage /ID# 217951

    Fort Wayne, Indiana, 46825

  • Signature Gyn Services /ID# 216354

    Fort Worth, Texas, 76104

  • Willowbend Health and Wellness - Frisco /ID# 217601

    Frisco, Texas, 75035

  • Womens Health Center /ID# 216235

    Glen Burnie, Maryland, 21063

  • University Medical Group /ID# 217954

    Greenville, South Carolina, 29605

  • Advanced Women's Health Institute /ID# 217342

    Greenwood Village, Colorado, 80111

  • Capital Women's Care - Hagerstown /ID# 217984

    Hagerstown, Maryland, 21740-6555

  • Penn State University and Milton S. Hershey Medical Center /ID# 213787

    Hershey, Pennsylvania, 17033-2360

  • UNC Hospitals - Hillsborough /ID# 218343

    Hillsborough, North Carolina, 27278-9078

  • Houston Methodist Hospital /ID# 216967

    Houston, Texas, 77030

  • Leavitt Womens Healthcare /ID# 221355

    Idaho Falls, Idaho, 83404-8322

  • Womens Healthcare Assoc, DBA /ID# 217839

    Idaho Falls, Idaho, 83404

  • University of Mississippi Medi /ID# 217636

    Jackson, Mississippi, 39216

  • Univ Kansas Med Ctr /ID# 216086

    Kansas City, Kansas, 66160

  • GYN Research Institute - Kissimmee /ID# 217979

    Kissimmee, Florida, 34741-4986

  • Altus Research, Inc /ID# 213740

    Lake Worth, Florida, 33461

  • R. Garn Mabey Jr, MD Chartered /ID# 218065

    Las Vegas, Nevada, 89128

  • Virginia Obstetrics & Gynecology /ID# 215797

    Leesburg, Virginia, 20176-3465

  • Olympia Clinical Trials /ID# 216238

    Los Angeles, California, 90036-4667

  • Norton Children's Gynecology /ID# 215671

    Louisville, Kentucky, 40207-4700

  • South Florida Wellness & Clinic /ID# 217637

    Margate, Florida, 33063

  • WellStar Kennestone Women's Health Clinic /ID# 216983

    Marietta, Georgia, 30060-1134

  • Cooper University Hospital/Sheridan Pavilion /ID# 218066

    Marlton, New Jersey, 08053-3464

  • Advanced Clinical Research /ID# 218346

    Meridian, Idaho, 83642

  • University of Miami /ID# 217952

    Miami, Florida, 33136

  • Palmetto Professional Research /ID# 218051

    Miami, Florida, 33186-1309

  • Women's Health Alliance of Mobile /ID# 213719

    Mobile, Alabama, 36604-1410

  • Mobile, Ob-Gyn, P.C. /ID# 217761

    Mobile, Alabama, 36608

  • West Virginia University /ID# 217664

    Morgantown, West Virginia, 26506

  • Venus Gynecology, LLC /ID# 213790

    Myrtle Beach, South Carolina, 29572

  • Paramount Research Solutions - Nashville /ID# 217341

    Nashville, Tennessee, 37203-2012

  • Urology Associates PC - Nashville /ID# 218139

    Nashville, Tennessee, 37209-4035

  • Jersey Shore University Medical Center /ID# 216488

    Neptune City, New Jersey, 07753-4859

  • Eastern Carolina Women's Centr /ID# 217335

    New Bern, North Carolina, 28562

  • Rutgers Robert Wood Johnson /ID# 216972

    New Brunswick, New Jersey, 08901

  • Yale University /ID# 217978

    New Haven, Connecticut, 06510

  • Ochsner Baptist Medical Centre /ID# 215762

    New Orleans, Louisiana, 70115

  • Manhattan Medical Research /ID# 217950

    New York, New York, 10016-6023

  • Mount Sinai Medical Center - NY /ID# 216208

    New York, New York, 10029-6501

  • Christiana Care Health Service /ID# 218097

    Newark, Delaware, 19713

  • Reproductive Assoc of Delaware /ID# 216082

    Newark, Delaware, 19713

  • Affinity Clinical Research /ID# 218203

    Oak Brook, Illinois, 60523

  • CHI Health /ID# 216074

    Omaha, Nebraska, 68131

  • A Premier Clinical Research of Florida, LLC /ID# 217949

    Orange City, Florida, 32763-2833

  • Camran Nezhat Institute /ID# 216083

    Palo Alto, California, 94304-1805

  • The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 217635

    Park Ridge, Illinois, 60068

  • Suffolk Obstetrics and Gyneco /ID# 213781

    Port Jefferson, New York, 11777

  • M3 Wake Research Inc. /ID# 217167

    Raleigh, North Carolina, 27612-8106

  • Virginia Women's Health Associates - Reston /ID# 217990

    Reston, Virginia, 20190-3215

  • Clinical Research Partners, LLC /ID# 216355

    Richmond, Virginia, 23220-4459

  • Granger Medical Clin-Riverton /ID# 218086

    Riverton, Utah, 84065

  • Central Michigan University Health /ID# 216237

    Saginaw, Michigan, 48602-5303

  • Saginaw Valley Med Res Group /ID# 217763

    Saginaw, Michigan, 48604

  • Univ Texas HSC San Antonio /ID# 218070

    San Antonio, Texas, 78229

  • Infertility, Gynecology & Obst /ID# 213734

    San Diego, California, 92121

  • West Coast Medical Research, I /ID# 217638

    San Diego, California, 92123-3357

  • Physician Care Clin. Res., LLC /ID# 216570

    Sarasota, Florida, 34239

  • Seattle Reproductive Medicine /ID# 213801

    Seattle, Washington, 98109

  • Womens & Family Care, LLC dba /ID# 216569

    Shawnee Mission, Kansas, 66218

  • LSUHSC - Shreveport /ID# 216229

    Shreveport, Louisiana, 71103

  • Omni Fertility and Laser Insti /ID# 217764

    Shreveport, Louisiana, 71118

  • Saint Louis University School of Medicine /ID# 217633

    St Louis, Missouri, 63104

  • Stamford Hospital /ID# 216975

    Stamford, Connecticut, 06902

  • Richmond OB/GYN Associates PC /ID# 217642

    Staten Island, New York, 10306

  • Island Reproductive Services - Staten Island /ID# 218202

    Staten Island, New York, 10309-2622

  • Palmetto Clinical Research /ID# 216076

    Summerville, South Carolina, 29485-7539

  • Women's Health Partners - Summerville /ID# 217339

    Summerville, South Carolina, 29485-8154

  • SUNY Upstate Medical University - Downtown /ID# 217596

    Syracuse, New York, 13210

  • GCP Clinical Research, LLC /ID# 218861

    Tampa, Florida, 33609-4044

  • University of South Florida /ID# 217606

    Tampa, Florida, 33612

  • Stedman Clinical Trials /ID# 217595

    Tampa, Florida, 33613

  • Visions Clinical Research-Tucs /ID# 216352

    Tucson, Arizona, 85712

  • The Chronic Pelvic Pain Center of Northern VA /ID# 217630

    Vienna, Virginia, 22182-2665

  • UnityPoint Clinic OB/GYN - Waterloo /ID# 216087

    Waterloo, Iowa, 50703-1901

  • Cypress Medical Research Ctr /ID# 218054

    Wichita, Kansas, 67226

  • UMass Memorial Health Care /ID# 217608

    Worcester, Massachusetts, 01605-2903

Other trials in United States

About this study

Official title: 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.

Keywords
Endometriosis, Chronic Pelvic Pain, Dysmenorrhea
Medical subject headings
Endometriosis, Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04140175
Study groupRoleWhat they receive
Women with suspected or confirmed endometriosisWomen with suspected or confirmed endometriosis undergoing standard of care treatments or interventions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants using specific medications for the treatment of chronic pelvic pain (CPP) and/or dysmenorrhea (DYS)

    Data regarding medication use for CPP and/or DYS will be collected from participant medical records, health care provider questionnaires, and participant completed questionnaires.

    Measured: From onset of CPP and/or DYS to up to 4 years following study enrollment.

  2. Percentage of participants who underwent surgical interventions for the treatment of CPP and/or DYS

    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.

    Measured: From onset of CPP and/or DYS to up to 4 years following study enrollment.

  3. Number of surgical interventions for the treatment of CPP and/or DYS

    Number of surgical interventions for the treatment of CPP and/or DYS.

    Measured: From onset of CPP and/or DYS to up to 4 years following study enrollment.

  4. Percentage of participants undergoing hysterectomy

    Percentage of participants undergoing hysterectomy during study enrollment.

    Measured: From study enrollment (Week 0) to up to 4 years.

  5. Percentage of participants undergoing infertility treatment

    Percentage of participants undergoing infertility treatments during study enrollment.

    Measured: From study enrollment (Week 0) to up to 4 years.

  6. Percentage of participants undergoing surgery

    Percentage of participants undergoing surgery as treatment for CPP and/or DYS.

    Measured: From study enrollment (Week 0) to up to 4 years.

  7. Percentage of participants with complications associated with surgery

    Percentage of participants with complications associated with surgery.

    Measured: From study enrollment (Week 0) to up to 4 years.

  8. Percentage of participants receiving specific treatment sequences for the treatment of CPP and/or DYS

    Treatment sequences will be identified from the data. Treatment switching, add-on treatment, and discontinuations (including reasons) will be collected wherever possible.

    Measured: From onset of CPP and/or DYS to up to 4 years following study enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2019
  2. Study start20 Jan 2020
  3. Primary completion19 Nov 2020
  4. Study completion19 Nov 2020

Why it stopped: Strategic considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04140175
Sponsor's protocol ID
P16-836
Status last verified
Nov 2021
First submitted
24 Oct 2019
Last updated
22 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis and Chronic Pelvic Pain, run by AbbVie at 117 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04140175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.

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