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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04140175
Other study ID # P16-836
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 20, 2020
Est. completion date November 19, 2020

Study information

Verified date November 2021
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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


Recruitment information / eligibility

Status Terminated
Enrollment 291
Est. completion date November 19, 2020
Est. primary completion date November 19, 2020
Accepts healthy volunteers No
Gender Female
Age group 12 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From onset of CPP and/or DYS to up to 4 years following study enrollment.
Primary 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. From onset of CPP and/or DYS to up to 4 years following study enrollment.
Primary Number of surgical interventions for the treatment of CPP and/or DYS 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.
Primary Percentage of participants undergoing hysterectomy Percentage of participants undergoing hysterectomy during study enrollment. From study enrollment (Week 0) to up to 4 years.
Primary Percentage of participants undergoing infertility treatment Percentage of participants undergoing infertility treatments during study enrollment. From study enrollment (Week 0) to up to 4 years.
Primary Percentage of participants undergoing surgery Percentage of participants undergoing surgery as treatment for CPP and/or DYS. From study enrollment (Week 0) to up to 4 years.
Primary Percentage of participants with complications associated with surgery Percentage of participants with complications associated with surgery. From study enrollment (Week 0) to up to 4 years.
Primary 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. From onset of CPP and/or DYS to up to 4 years following study enrollment.
See also
  Status Clinical Trial Phase
Completed NCT01931670 - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain Phase 3
Recruiting NCT05648669 - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain Phase 3
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed NCT03690765 - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting NCT05153512 - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Completed NCT04565470 - Strategies of Self-management of Endometriosis Symptoms
Completed NCT03613298 - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement. N/A
Withdrawn NCT05568940 - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting NCT03464799 - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting NCT03002870 - Characteristics of Patient Population With Endometriosis N/A
Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Withdrawn NCT03272360 - Endometriosis Biomarker Discovery Study N/A
Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4

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