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.

Stopped early

Conditions studied: Endometriosis, Chronic Pelvic Pain, Dysmenorrhea

In brief

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.

Key facts

Study ID

NCT04140175

Run by

AbbVie

People needed

291

Starts

2020-01-20

Expected to finish

2020-11-19

Last updated by the study team

2021-11-22

Who can join

Age: 12 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Atlanta VAMC /ID# 215763 — Decatur, Alabama, United States
• Brown, Pearson, Guepet Gynecology /ID# 215500 — Fairhope, Alabama, United States
• Women's Health Alliance of Mobile /ID# 213719 — Mobile, Alabama, United States
• Mobile, Ob-Gyn, P.C. /ID# 217761 — Mobile, Alabama, United States
• Visions Clinical Research-Tucs /ID# 216352 — Tucson, Arizona, United States
• Olympia Clinical Trials /ID# 216238 — Los Angeles, California, United States
• Camran Nezhat Institute /ID# 216083 — Palo Alto, California, United States
• Infertility, Gynecology & Obst /ID# 213734 — San Diego, California, United States
• West Coast Medical Research, I /ID# 217638 — San Diego, California, United States
• Women's Care Clinic - Denver Health Main Campus /ID# 217975 — Denver, Colorado, United States
• Advanced Women's Health Institute /ID# 217342 — Greenwood Village, Colorado, United States
• Yale University /ID# 217978 — New Haven, Connecticut, United States
• Stamford Hospital /ID# 216975 — Stamford, Connecticut, United States
• Christiana Care Health Service /ID# 218097 — Newark, Delaware, United States
• Reproductive Assoc of Delaware /ID# 216082 — Newark, Delaware, United States
• Women's Medical Research Group /ID# 216230 — Clearwater, Florida, United States
• GYN Research Institute - Kissimmee /ID# 217979 — Kissimmee, Florida, United States
• Altus Research, Inc /ID# 213740 — Lake Worth, Florida, United States
• South Florida Wellness & Clinic /ID# 217637 — Margate, Florida, United States
• University of Miami /ID# 217952 — Miami, 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
• GCP Clinical Research, LLC /ID# 218861 — Tampa, Florida, United States
• University of Alabama at Birmingham - Women's and Infant's Center /ID# 216236 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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