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.

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04140175
• Other study ID #: P16-836
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Dysmenorrhea
• Endometriosis
• Pelvic Pain

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.

External Links

•   clinical study report synopsis