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.
- Conditions
- DysmenorrheaEndometriosisChronic Pelvic Pain
- Registration Number
- NCT04140175
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 291
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants who underwent 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 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.
Percentage of participants undergoing hysterectomy From study enrollment (Week 0) to up to 4 years. Percentage of participants undergoing hysterectomy during study enrollment.
Percentage of participants undergoing infertility treatment From study enrollment (Week 0) to up to 4 years. Percentage of participants undergoing infertility treatments during study enrollment.
Percentage of participants undergoing surgery From study enrollment (Week 0) to up to 4 years. Percentage of participants undergoing surgery as treatment for CPP and/or DYS.
Percentage of participants receiving specific treatment sequences for the treatment of CPP and/or DYS 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.
Percentage of participants using specific medications for the treatment of chronic pelvic pain (CPP) and/or dysmenorrhea (DYS) 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.
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. Number of surgical interventions for the treatment of CPP and/or DYS.
Percentage of participants with complications associated with surgery From study enrollment (Week 0) to up to 4 years. Percentage of participants with complications associated with surgery.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (117)
Capital Women's Care - Hagerstown /ID# 217984
🇺🇸Hagerstown, Maryland, United States
Stamford Hospital /ID# 216975
🇺🇸Stamford, Connecticut, United States
Agile Clinical Research Trials /ID# 217762
🇺🇸Atlanta, Georgia, United States
Emory Saint Joseph's Hospital /ID# 213746
🇺🇸Atlanta, Georgia, United States
Aventiv Research, Inc. /ID# 221293
🇺🇸Columbus, Ohio, United States
Altus Research, Inc /ID# 213740
🇺🇸Lake Worth, Florida, United States
GYN Research Institute - Kissimmee /ID# 217979
🇺🇸Kissimmee, Florida, United States
Visions Clinical Research-Tucs /ID# 216352
🇺🇸Tucson, Arizona, United States
Advanced Women's Health Institute /ID# 217342
🇺🇸Greenwood Village, Colorado, United States
Mobile, Ob-Gyn, P.C. /ID# 217761
🇺🇸Mobile, Alabama, United States
Methodist Dallas Medical Center /ID# 218350
🇺🇸Dallas, Texas, United States
West Virginia University /ID# 217664
🇺🇸Morgantown, West Virginia, United States
The Women's Centre /ID# 213794
🇺🇸Denton, Texas, United States
Virginia Women's Health Associates - Reston /ID# 217990
🇺🇸Reston, Virginia, United States
Virginia Obstetrics & Gynecology /ID# 215797
🇺🇸Leesburg, Virginia, United States
Signature Gyn Services /ID# 216354
🇺🇸Fort Worth, Texas, United States
Granger Medical Clin-Riverton /ID# 218086
🇺🇸Riverton, Utah, United States
Willowbend Health and Wellness - Frisco /ID# 217601
🇺🇸Frisco, Texas, United States
The Chronic Pelvic Pain Center of Northern VA /ID# 217630
🇺🇸Vienna, Virginia, United States
Houston Methodist Hospital /ID# 216967
🇺🇸Houston, Texas, United States
Seattle Reproductive Medicine /ID# 213801
🇺🇸Seattle, Washington, United States
University of Miami /ID# 217952
🇺🇸Miami, Florida, United States
Infertility, Gynecology & Obst /ID# 213734
🇺🇸San Diego, California, United States
West Coast Medical Research, I /ID# 217638
🇺🇸San Diego, California, United States
Carolina Women's Research and Wellness Center /ID# 216962
🇺🇸Durham, North Carolina, United States
Paramount Research Solutions - Nashville /ID# 217341
🇺🇸Nashville, Tennessee, United States
Urology Associates PC - Nashville /ID# 218139
🇺🇸Nashville, Tennessee, United States
Univ Texas HSC San Antonio /ID# 218070
🇺🇸San Antonio, Texas, United States
Atlanta VAMC /ID# 215763
🇺🇸Decatur, Alabama, United States
Women's Health Alliance of Mobile /ID# 213719
🇺🇸Mobile, Alabama, United States
Olympia Clinical Trials /ID# 216238
🇺🇸Los Angeles, California, United States
Camran Nezhat Institute /ID# 216083
🇺🇸Palo Alto, California, United States
Christiana Care Health Service /ID# 218097
🇺🇸Newark, Delaware, United States
Women's Medical Research Group /ID# 216230
🇺🇸Clearwater, Florida, United States
South Florida Wellness & Clinic /ID# 217637
🇺🇸Margate, Florida, United States
Palmetto Professional Research /ID# 218051
🇺🇸Miami, Florida, United States
A Premier Clinical Research of Florida, LLC /ID# 217949
🇺🇸Orange City, Florida, United States
Physician Care Clin. Res., LLC /ID# 216570
🇺🇸Sarasota, Florida, United States
Journey Medical Research Insti /ID# 216077
🇺🇸Alpharetta, Georgia, United States
Academia Women's Health /ID# 218075
🇺🇸Atlanta, Georgia, United States
Atlanta Women's Research Inst /ID# 216571
🇺🇸Atlanta, Georgia, United States
Medisense Inc /ID# 218342
🇺🇸Atlanta, Georgia, United States
WellStar Kennestone Women's Health Clinic /ID# 216983
🇺🇸Marietta, Georgia, United States
Leavitt Womens Healthcare /ID# 221355
🇺🇸Idaho Falls, Idaho, United States
Womens Healthcare Assoc, DBA /ID# 217839
🇺🇸Idaho Falls, Idaho, United States
Advanced Clinical Research /ID# 218346
🇺🇸Meridian, Idaho, United States
Women's Health Practice, LLC /ID# 216964
🇺🇸Champaign, Illinois, United States
Northwestern Medicine Fertility and Reproductive Medicine /ID# 217662
🇺🇸Chicago, Illinois, United States
Affinity Clinical Research /ID# 218203
🇺🇸Oak Brook, Illinois, United States
The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 217635
🇺🇸Park Ridge, Illinois, United States
Women's Health Advantage /ID# 217951
🇺🇸Fort Wayne, Indiana, United States
UnityPoint Clinic OB/GYN - Waterloo /ID# 216087
🇺🇸Waterloo, Iowa, United States
Cypress Medical Research Ctr /ID# 218054
🇺🇸Wichita, Kansas, United States
Womens & Family Care, LLC dba /ID# 216569
🇺🇸Shawnee Mission, Kansas, United States
Horizon Research Group /ID# 217337
🇺🇸Eunice, Louisiana, United States
Omni Fertility and Laser Insti /ID# 217764
🇺🇸Shreveport, Louisiana, United States
MaineGeneral Obstetrics & Gynecology /ID# 217634
🇺🇸Augusta, Maine, United States
Johns Hopkins University /ID# 217958
🇺🇸Baltimore, Maryland, United States
Boston Medical Center /ID# 218344
🇺🇸Boston, Massachusetts, United States
Hanjani PC /ID# 217953
🇺🇸Brockton, Massachusetts, United States
Boston Urogynecology Associates /ID# 216232
🇺🇸Cambridge, Massachusetts, United States
NECCR Fall River LLC /ID# 216079
🇺🇸Fall River, Massachusetts, United States
UMass Memorial Health Care /ID# 217608
🇺🇸Worcester, Massachusetts, United States
Great Lakes Research, Inc. /ID# 215764
🇺🇸Bay City, Michigan, United States
Central Michigan University Health /ID# 216237
🇺🇸Saginaw, Michigan, United States
Saginaw Valley Med Res Group /ID# 217763
🇺🇸Saginaw, Michigan, United States
University of Mississippi Medi /ID# 217636
🇺🇸Jackson, Mississippi, United States
Saint Louis University School of Medicine /ID# 217633
🇺🇸Saint Louis, Missouri, United States
CHI Health /ID# 216074
🇺🇸Omaha, Nebraska, United States
Cooper University Hospital/Sheridan Pavilion /ID# 218066
🇺🇸Marlton, New Jersey, United States
Jersey Shore University Medical Center /ID# 216488
🇺🇸Neptune, New Jersey, United States
R. Garn Mabey Jr, MD Chartered /ID# 218065
🇺🇸Las Vegas, Nevada, United States
Circuit Clinical - Buffalo /ID# 217656
🇺🇸Buffalo, New York, United States
Rutgers Robert Wood Johnson /ID# 216972
🇺🇸New Brunswick, New Jersey, United States
University of Alabama at Birmingham - Women's and Infant's Center /ID# 216236
🇺🇸Birmingham, Alabama, United States
Women's Care Clinic - Denver Health Main Campus /ID# 217975
🇺🇸Denver, Colorado, United States
Widewaters Gynecology /ID# 217661
🇺🇸East Syracuse, New York, United States
Manhattan Medical Research /ID# 217950
🇺🇸New York, New York, United States
Mount Sinai Medical Center - NY /ID# 216208
🇺🇸New York, New York, United States
Suffolk Obstetrics and Gyneco /ID# 213781
🇺🇸Port Jefferson, New York, United States
Richmond OB/GYN Associates PC /ID# 217642
🇺🇸Staten Island, New York, United States
Island Reproductive Services - Staten Island /ID# 218202
🇺🇸Staten Island, New York, United States
SUNY Upstate Medical University - Downtown /ID# 217596
🇺🇸Syracuse, New York, United States
MAHEC OB/GYN Specialists /ID# 216973
🇺🇸Asheville, North Carolina, United States
UNC Hospitals - Hillsborough /ID# 218343
🇺🇸Hillsborough, North Carolina, United States
Eastern Carolina Women's Centr /ID# 217335
🇺🇸New Bern, North Carolina, United States
M3 Wake Research Inc. /ID# 217167
🇺🇸Raleigh, North Carolina, United States
Univ of Cincinnati Physicians /ID# 217643
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland /ID# 216075
🇺🇸Cleveland, Ohio, United States
MetroHealth Medical Center /ID# 217169
🇺🇸Cleveland, Ohio, United States
Complete Healthcare for Women /ID# 216961
🇺🇸Columbus, Ohio, United States
Wright State Univ, School Med /ID# 216084
🇺🇸Dayton, Ohio, United States
Abington Reproductive Medicine /ID# 216575
🇺🇸Abington, Pennsylvania, United States
Penn State University and Milton S. Hershey Medical Center /ID# 213787
🇺🇸Hershey, Pennsylvania, United States
Vista Clinical Research /ID# 213789
🇺🇸Columbia, South Carolina, United States
University Medical Group /ID# 217954
🇺🇸Greenville, South Carolina, United States
Venus Gynecology, LLC /ID# 213790
🇺🇸Myrtle Beach, South Carolina, United States
Palmetto Clinical Research /ID# 216076
🇺🇸Summerville, South Carolina, United States
Women's Health Partners - Summerville /ID# 217339
🇺🇸Summerville, South Carolina, United States
Chattanoogas Program in Womens /ID# 218052
🇺🇸Chattanooga, Tennessee, United States
Chattanooga Medical Research /ID# 217594
🇺🇸Chattanooga, Tennessee, United States
Physicians Research Options, L /ID# 213799
🇺🇸Draper, Utah, United States
GCP Clinical Research, LLC /ID# 218861
🇺🇸Tampa, Florida, United States
University of South Florida /ID# 217606
🇺🇸Tampa, Florida, United States
Stedman Clinical Trials /ID# 217595
🇺🇸Tampa, Florida, United States
Brown, Pearson, Guepet Gynecology /ID# 215500
🇺🇸Fairhope, Alabama, United States
Augusta OB/GYN Specialists LLC /ID# 218076
🇺🇸Augusta, Georgia, United States
Paramount Research Solutions - College Park /ID# 217959
🇺🇸College Park, Georgia, United States
Norton Children's Gynecology /ID# 215671
🇺🇸Louisville, Kentucky, United States
Yale University /ID# 217978
🇺🇸New Haven, Connecticut, United States
Reproductive Assoc of Delaware /ID# 216082
🇺🇸Newark, Delaware, United States
LSUHSC - Shreveport /ID# 216229
🇺🇸Shreveport, Louisiana, United States
University of Maryland Med Ctr /ID# 216080
🇺🇸Baltimore, Maryland, United States
Womens Health Center /ID# 216235
🇺🇸Glen Burnie, Maryland, United States
Ochsner Baptist Medical Centre /ID# 215762
🇺🇸New Orleans, Louisiana, United States
Clinical Research Partners, LLC /ID# 216355
🇺🇸Richmond, Virginia, United States
Univ Kansas Med Ctr /ID# 216086
🇺🇸Kansas City, Kansas, United States