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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.

Sponsor
AbbVie (Industry)
Overall Status
Terminated
CT.gov ID
NCT04140175
Collaborator
(none)
291
Enrollment
117
Locations
10
Actual Duration (Months)
2.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    291 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jan 20, 2020
    Actual Primary Completion Date :
    Nov 19, 2020
    Actual Study Completion Date :
    Nov 19, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Women with suspected or confirmed endometriosis

    Women with suspected or confirmed endometriosis undergoing standard of care treatments or interventions.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. Percentage of participants undergoing hysterectomy [From study enrollment (Week 0) to up to 4 years.]

      Percentage of participants undergoing hysterectomy during study enrollment.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04140175
    Other Study ID Numbers:
    • P16-836
    First Posted:
    Oct 25, 2019
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by AbbVie
    Endometriosis
    Chronic Pelvic Pain
    Dysmenorrhea
    Additional relevant MeSH terms:
    Endometriosis
    Pelvic Pain
    Dysmenorrhea

    Study Results

    No Results Posted as of Nov 22, 2021