Clinical trial NCT04140175: 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.
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Endometriosis
Chronic Pelvic Pain
Dysmenorrhea
Keywords: Endometriosis
Chronic Pelvic Pain
Dysmenorrhea
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-10-25
Enrollment: 291
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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. Length of treatment is dependent on standard of care treatment provided and all study information will be collected during routine standard of care visits.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants using specific medications for the treatment of chronic pelvic pain (CPP) and/or dysmenorrhea (DYS)
timeFrame: From onset of CPP and/or DYS to up to 4 years following study enrollment.
measure: Percentage of participants who underwent surgical interventions for the treatment of CPP and/or DYS
timeFrame: From onset of CPP and/or DYS to up to 4 years following study enrollment.
measure: Number of surgical interventions for the treatment of CPP and/or DYS
timeFrame: From onset of CPP and/or DYS to up to 4 years following study enrollment.
measure: Percentage of participants undergoing hysterectomy
timeFrame: From study enrollment (Week 0) to up to 4 years.
measure: Percentage of participants undergoing infertility treatment
timeFrame: From study enrollment (Week 0) to up to 4 years.
measure: Percentage of participants undergoing surgery
timeFrame: From study enrollment (Week 0) to up to 4 years.
measure: Percentage of participants with complications associated with surgery
timeFrame: From study enrollment (Week 0) to up to 4 years.
measure: Percentage of participants receiving specific treatment sequences for the treatment of CPP and/or DYS
timeFrame: From onset of CPP and/or DYS to up to 4 years following study enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Women's and Infant's Center /ID# 216236
state: Alabama
city: Decatur
country: United States
facility: Atlanta VAMC /ID# 215763
state: Alabama
city: Fairhope
country: United States
facility: Brown, Pearson, Guepet Gynecology /ID# 215500
state: Alabama
city: Mobile
country: United States
facility: Women's Health Alliance of Mobile /ID# 213719
state: Alabama
city: Mobile
country: United States
facility: Mobile, Ob-Gyn, P.C. /ID# 217761
state: Alabama
city: Tucson
country: United States
facility: Visions Clinical Research-Tucs /ID# 216352
state: Arizona
city: Los Angeles
country: United States
facility: Olympia Clinical Trials /ID# 216238
state: California
city: Palo Alto
country: United States
facility: Camran Nezhat Institute /ID# 216083
state: California
city: San Diego
country: United States
facility: Infertility, Gynecology & Obst /ID# 213734
state: California
city: San Diego
country: United States
facility: West Coast Medical Research, I /ID# 217638
state: California
city: Denver
country: United States
facility: Women's Care Clinic - Denver Health Main Campus /ID# 217975
state: Colorado
city: Greenwood Village
country: United States
facility: Advanced Women's Health Institute /ID# 217342
state: Colorado
city: New Haven
country: United States
facility: Yale University /ID# 217978
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital /ID# 216975
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Service /ID# 218097
state: Delaware
city: Newark
country: United States
facility: Reproductive Assoc of Delaware /ID# 216082
state: Delaware
city: Clearwater
country: United States
facility: Women's Medical Research Group /ID# 216230
state: Florida
city: Kissimmee
country: United States
facility: GYN Research Institute - Kissimmee /ID# 217979
state: Florida
city: Lake Worth
country: United States
facility: Altus Research, Inc /ID# 213740
state: Florida
city: Margate
country: United States
facility: South Florida Wellness & Clinic /ID# 217637
state: Florida
city: Miami
country: United States
facility: University of Miami /ID# 217952
state: Florida
city: Miami
country: United States
facility: Palmetto Professional Research /ID# 218051
state: Florida
city: Orange City
country: United States
facility: A Premier Clinical Research of Florida, LLC /ID# 217949
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clin. Res., LLC /ID# 216570
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research, LLC /ID# 218861
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 217606
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials /ID# 217595
state: Florida
city: Alpharetta
country: United States
facility: Journey Medical Research Insti /ID# 216077
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Research Trials /ID# 217762
state: Georgia
city: Atlanta
country: United States
facility: Academia Women's Health /ID# 218075
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital /ID# 213746
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Women's Research Inst /ID# 216571
state: Georgia
city: Atlanta
country: United States
facility: Medisense Inc /ID# 218342
state: Georgia
city: Augusta
country: United States
facility: Augusta OB/GYN Specialists LLC /ID# 218076
state: Georgia
city: College Park
country: United States
facility: Paramount Research Solutions - College Park /ID# 217959
state: Georgia
city: Marietta
country: United States
facility: WellStar Kennestone Women's Health Clinic /ID# 216983
state: Georgia
city: Idaho Falls
country: United States
facility: Leavitt Womens Healthcare /ID# 221355
state: Idaho
city: Idaho Falls
country: United States
facility: Womens Healthcare Assoc, DBA /ID# 217839
state: Idaho
city: Meridian
country: United States
facility: Advanced Clinical Research /ID# 218346
state: Idaho
city: Champaign
country: United States
facility: Women's Health Practice, LLC /ID# 216964
state: Illinois
city: Chicago
country: United States
facility: Northwestern Medicine Fertility and Reproductive Medicine /ID# 217662
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Clinical Research /ID# 218203
state: Illinois
city: Park Ridge
country: United States
facility: The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 217635
state: Illinois
city: Fort Wayne
country: United States
facility: Women's Health Advantage /ID# 217951
state: Indiana
city: Waterloo
country: United States
facility: UnityPoint Clinic OB/GYN - Waterloo /ID# 216087
state: Iowa
city: Kansas City
country: United States
facility: Univ Kansas Med Ctr /ID# 216086
state: Kansas
city: Shawnee Mission
country: United States
facility: Womens & Family Care, LLC dba /ID# 216569
state: Kansas
city: Wichita
country: United States
facility: Cypress Medical Research Ctr /ID# 218054
state: Kansas
city: Louisville
country: United States
facility: Norton Children's Gynecology /ID# 215671
state: Kentucky
city: Eunice
country: United States
facility: Horizon Research Group /ID# 217337
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Centre /ID# 215762
state: Louisiana
city: Shreveport
country: United States
facility: LSUHSC - Shreveport /ID# 216229
state: Louisiana
city: Shreveport
country: United States
facility: Omni Fertility and Laser Insti /ID# 217764
state: Louisiana
city: Augusta
country: United States
facility: MaineGeneral Obstetrics & Gynecology /ID# 217634
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Med Ctr /ID# 216080
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University /ID# 217958
state: Maryland
city: Glen Burnie
country: United States
facility: Womens Health Center /ID# 216235
state: Maryland
city: Hagerstown
country: United States
facility: Capital Women's Care - Hagerstown /ID# 217984
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center /ID# 218344
state: Massachusetts
city: Brockton
country: United States
facility: Hanjani PC /ID# 217953
state: Massachusetts
city: Cambridge
country: United States
facility: Boston Urogynecology Associates /ID# 216232
state: Massachusetts
city: Fall River
country: United States
facility: NECCR Fall River LLC /ID# 216079
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Health Care /ID# 217608
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research, Inc. /ID# 215764
state: Michigan
city: Saginaw
country: United States
facility: Central Michigan University Health /ID# 216237
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Med Res Group /ID# 217763
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medi /ID# 217636
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University School of Medicine /ID# 217633
state: Missouri
city: Omaha
country: United States
facility: CHI Health /ID# 216074
state: Nebraska
city: Las Vegas
country: United States
facility: R. Garn Mabey Jr, MD Chartered /ID# 218065
state: Nevada
city: Marlton
country: United States
facility: Cooper University Hospital/Sheridan Pavilion /ID# 218066
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center /ID# 216488
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson /ID# 216972
state: New Jersey
city: Buffalo
country: United States
facility: Circuit Clinical - Buffalo /ID# 217656
state: New York
city: East Syracuse
country: United States
facility: Widewaters Gynecology /ID# 217661
state: New York
city: New York
country: United States
facility: Manhattan Medical Research /ID# 217950
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center - NY /ID# 216208
state: New York
city: Port Jefferson
country: United States
facility: Suffolk Obstetrics and Gyneco /ID# 213781
state: New York
city: Staten Island
country: United States
facility: Richmond OB/GYN Associates PC /ID# 217642
state: New York
city: Staten Island
country: United States
facility: Island Reproductive Services - Staten Island /ID# 218202
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University - Downtown /ID# 217596
state: New York
city: Asheville
country: United States
facility: MAHEC OB/GYN Specialists /ID# 216973
state: North Carolina
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center /ID# 216962
state: North Carolina
city: Hillsborough
country: United States
facility: UNC Hospitals - Hillsborough /ID# 218343
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Centr /ID# 217335
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research Inc. /ID# 217167
state: North Carolina
city: Cincinnati
country: United States
facility: Univ of Cincinnati Physicians /ID# 217643
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland /ID# 216075
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center /ID# 217169
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc. /ID# 221293
state: Ohio
city: Columbus
country: United States
facility: Complete Healthcare for Women /ID# 216961
state: Ohio
city: Dayton
country: United States
facility: Wright State Univ, School Med /ID# 216084
state: Ohio
city: Abington
country: United States
facility: Abington Reproductive Medicine /ID# 216575
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University and Milton S. Hershey Medical Center /ID# 213787
state: Pennsylvania
city: Columbia
country: United States
facility: Vista Clinical Research /ID# 213789
state: South Carolina
city: Greenville
country: United States
facility: University Medical Group /ID# 217954
state: South Carolina
city: Myrtle Beach
country: United States
facility: Venus Gynecology, LLC /ID# 213790
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research /ID# 216076
state: South Carolina
city: Summerville
country: United States
facility: Women's Health Partners - Summerville /ID# 217339
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanoogas Program in Womens /ID# 218052
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga Medical Research /ID# 217594
state: Tennessee
city: Nashville
country: United States
facility: Paramount Research Solutions - Nashville /ID# 217341
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates PC - Nashville /ID# 218139
state: Tennessee
city: Dallas
country: United States
facility: Methodist Dallas Medical Center /ID# 218350
state: Texas
city: Denton
country: United States
facility: The Women's Centre /ID# 213794
state: Texas
city: Fort Worth
country: United States
facility: Signature Gyn Services /ID# 216354
state: Texas
city: Frisco
country: United States
facility: Willowbend Health and Wellness - Frisco /ID# 217601
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital /ID# 216967
state: Texas
city: San Antonio
country: United States
facility: Univ Texas HSC San Antonio /ID# 218070
state: Texas
city: Draper
country: United States
facility: Physicians Research Options, L /ID# 213799
state: Utah
city: Riverton
country: United States
facility: Granger Medical Clin-Riverton /ID# 218086
state: Utah
city: Leesburg
country: United States
facility: Virginia Obstetrics & Gynecology /ID# 215797
state: Virginia
city: Reston
country: United States
facility: Virginia Women's Health Associates - Reston /ID# 217990
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC /ID# 216355
state: Virginia
city: Vienna
country: United States
facility: The Chronic Pelvic Pain Center of Northern VA /ID# 217630
state: Virginia
city: Seattle
country: United States
facility: Seattle Reproductive Medicine /ID# 213801
state: Washington
city: Morgantown
country: United States
facility: West Virginia University /ID# 217664
state: West Virginia
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: