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Trial record 2 of 2 for:    abbVie | Recruiting Studies | Endometriosis

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.

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ClinicalTrials.gov Identifier: NCT04140175
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Endometriosis Chronic Pelvic Pain Dysmenorrhea

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : November 26, 2023
Estimated Study Completion Date : November 26, 2023

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Percentage of participants using specific medications for the treatment of chronic pelvic pain (CPP) and/or dysmenorrhea (DYS) [ Time Frame: 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.

  2. Percentage of participants who underwent surgical interventions for the treatment of CPP and/or DYS [ Time Frame: 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.

  3. Number of surgical interventions for the treatment of CPP and/or DYS [ Time Frame: 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.

  4. Percentage of participants undergoing hysterectomy [ Time Frame: From study enrollment (Week 0) to up to 4 years. ]
    Percentage of participants undergoing hysterectomy during study enrollment.

  5. Percentage of participants undergoing infertility treatment [ Time Frame: From study enrollment (Week 0) to up to 4 years. ]
    Percentage of participants undergoing infertility treatments during study enrollment.

  6. Percentage of participants undergoing surgery [ Time Frame: From study enrollment (Week 0) to up to 4 years. ]
    Percentage of participants undergoing surgery as treatment for CPP and/or DYS.

  7. Percentage of participants with complications associated with surgery [ Time Frame: From study enrollment (Week 0) to up to 4 years. ]
    Percentage of participants with complications associated with surgery.

  8. Percentage of participants receiving specific treatment sequences for the treatment of CPP and/or DYS [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll women of reproductive age (between first onset of menses and before onset of menopause) with a suspected or confirmed diagnosis of endometriosis.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140175


Contacts
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Contact: Horia Ijacu 224-254-8247 horia.ijacu@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04140175    
Other Study ID Numbers: P16-836
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Endometriosis
Chronic Pelvic Pain
Dysmenorrhea
Additional relevant MeSH terms:
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Endometriosis
Pelvic Pain
Dysmenorrhea
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms
Menstruation Disturbances
Pathologic Processes