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.

Terminated

• Conditions: Dysmenorrhea; Endometriosis; Chronic Pelvic Pain

• Registration Number: NCT04140175
• Lead Sponsor: AbbVie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-25
• Study Start: 2020-01-20
• Primary Completion: 2020-11-19
• Study Completion: 2020-11-19
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 291

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants who underwent 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.	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.
Percentage of participants undergoing hysterectomy	From study enrollment (Week 0) to up to 4 years.	Percentage of participants undergoing hysterectomy during study enrollment.
Percentage of participants undergoing infertility treatment	From study enrollment (Week 0) to up to 4 years.	Percentage of participants undergoing infertility treatments during study enrollment.
Percentage of participants undergoing surgery	From study enrollment (Week 0) to up to 4 years.	Percentage of participants undergoing surgery as treatment for CPP and/or DYS.
Percentage of participants receiving specific treatment sequences for the treatment of CPP and/or DYS	From onset of CPP and/or DYS to up to 4 years following study enrollment.	Treatment sequences will be identified from the data. Treatment switching, add-on treatment, and discontinuations (including reasons) will be collected wherever possible.
Percentage of participants using specific medications for the treatment of chronic pelvic pain (CPP) and/or dysmenorrhea (DYS)	From onset of CPP and/or DYS to up to 4 years following study enrollment.	Data regarding medication use for CPP and/or DYS will be collected from participant medical records, health care provider questionnaires, and participant completed questionnaires.
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.	Number of surgical interventions for the treatment of CPP and/or DYS.
Percentage of participants with complications associated with surgery	From study enrollment (Week 0) to up to 4 years.	Percentage of participants with complications associated with surgery.

Trial Locations

Locations (117)

University of Alabama at Birmingham - Women's and Infant's Center /ID# 216236; 🇺🇸 Birmingham, Alabama, United States

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

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