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.

AbbVie

Status: Terminated

Conditions: Chronic Pelvic Pain; Dysmenorrhea; Endometriosis

Study type: Observational

Funder types: Industry

Identifiers

NCT04140175

P16-836

Details and patient eligibility

About

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.

Enrollment: 291 patients

Sex: Female

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

291 participants in 1 patient group

Women with suspected or confirmed endometriosis

Description:

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