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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

Tracking Information
First Submitted Date October 24, 2019
First Posted Date October 25, 2019
Last Update Posted Date January 23, 2020
Actual Study Start Date January 20, 2020
Estimated Primary Completion Date November 26, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 24, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Endometriosis
  • Chronic Pelvic Pain
  • Dysmenorrhea
Intervention Not Provided
Study Groups/Cohorts Women with suspected or confirmed endometriosis
Women with suspected or confirmed endometriosis undergoing standard of care treatments or interventions.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 24, 2019)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 26, 2023
Estimated Primary Completion Date November 26, 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Horia Ijacu 224-254-8247 horia.ijacu@abbvie.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04140175
Other Study ID Numbers P16-836
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date January 2020