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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.

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

291 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-20

Study Completion Date

2020-11-19

Brief Summary

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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

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Conditions

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Endometriosis Chronic Pelvic Pain Dysmenorrhea

Keywords

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Endometriosis Chronic Pelvic Pain Dysmenorrhea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with suspected or confirmed endometriosis

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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University of Alabama at Birmingham - Women's and Infant's Center /ID# 216236

Birmingham, Alabama, United States

Site Status

Atlanta VAMC /ID# 215763

Decatur, Alabama, United States

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Brown, Pearson, Guepet Gynecology /ID# 215500

Fairhope, Alabama, United States

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Women's Health Alliance of Mobile /ID# 213719

Mobile, Alabama, United States

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Mobile, Ob-Gyn, P.C. /ID# 217761

Mobile, Alabama, United States

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Visions Clinical Research-Tucs /ID# 216352

Tucson, Arizona, United States

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Olympia Clinical Trials /ID# 216238

Los Angeles, California, United States

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Camran Nezhat Institute /ID# 216083

Palo Alto, California, United States

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Infertility, Gynecology & Obst /ID# 213734

San Diego, California, United States

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West Coast Medical Research, I /ID# 217638

San Diego, California, United States

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Women's Care Clinic - Denver Health Main Campus /ID# 217975

Denver, Colorado, United States

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Advanced Women's Health Institute /ID# 217342

Greenwood Village, Colorado, United States

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Yale University /ID# 217978

New Haven, Connecticut, United States

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Stamford Hospital /ID# 216975

Stamford, Connecticut, United States

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Christiana Care Health Service /ID# 218097

Newark, Delaware, United States

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Reproductive Assoc of Delaware /ID# 216082

Newark, Delaware, United States

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Women's Medical Research Group /ID# 216230

Clearwater, Florida, United States

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GYN Research Institute - Kissimmee /ID# 217979

Kissimmee, Florida, United States

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Altus Research, Inc /ID# 213740

Lake Worth, Florida, United States

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South Florida Wellness & Clinic /ID# 217637

Margate, Florida, United States

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University of Miami /ID# 217952

Miami, Florida, United States

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Palmetto Professional Research /ID# 218051

Miami, Florida, United States

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A Premier Clinical Research of Florida, LLC /ID# 217949

Orange City, Florida, United States

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Physician Care Clin. Res., LLC /ID# 216570

Sarasota, Florida, United States

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GCP Clinical Research, LLC /ID# 218861

Tampa, Florida, United States

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University of South Florida /ID# 217606

Tampa, Florida, United States

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Stedman Clinical Trials /ID# 217595

Tampa, Florida, United States

Site Status