Clinical trial NCT05026502: A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Official title: Real-world Experience of Elagolix With E2/NETA for the Treatment of Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF): an Observational Study (The REACH Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heavy Menstrual Bleeding
Uterine Fibroids
Keywords: Elagolix
Estradiol/Norethindrone Acetate (E2/NETA)
Oriahnn
ABT-620
Heavy Menstrual Bleeding (HMB)
Uterine Fibroids (UF)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female participants diagnosed with heavy menstrual bleeding associated with uterine fibroids who have been prescribed elagolix + E2/NETA as part of standard of care

Brief summary: Uterine Fibroids (UF) are noncancerous (benign) tumors that commonly occur in up to 80% of women of reproductive age. Symptoms can include heavy menstrual bleeding (HMB), low back pain, urinary frequency and urgency, gastrointestinal symptoms, and fatigue. In participants with UF, this study will prospectively assess changes in patient-reported quality of life and patient-reported effectiveness in controlling HMB when treated with elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules (elagolix + E2/NETA).

Around 200 adult premenopausal female participants in the United States with a diagnosis of HMB associated with UF and are prescribed elagolix + E2/NETA by their physicians as per standard of care will be enrolled in this direct-to-patient observational study for up to 6 months.

Participants will have been prescribed elagolix + E2/NETA within the last 30 days prior to enrollment and will continue to take elagolix + E2/NETA throughout study participation.

There may be a higher burden for participants in this study compared to standard of care. Electronic patient reported outcomes (ePROs) will be collected at baseline, 1, 3 and 6 months to assess the impact of Elagolix + E2/NETA on patient-reported quality of life.


Eligibility criteria: Inclusion Criteria:

* Participants who have initiated elagolix + Estradiol/Norethindrone Acetate (E2/NETA) in the last 30 days or less, or with planned initiation of elagolix + E2/NETA prescribed as part of standard of care treatment.
* Participants self-reporting heavy menstrual bleeding (HMB) associated with uterine fibroids (UF).
* Participants are premenopausal (i.e., still report experiencing menses).

Exclusion Criteria:

* Participants that report they are pregnant or planning to become pregnant in next 6 months.
* Participants reporting a surgical history of:

  * Hysterectomy (with or without oophorectomy).
  * Bilateral oophorectomy.
* Participants who have initiated elagolix + E2/NETA more than 30 days ago.

Primary outcomes:
measure: Change From Baseline in Self-Reported Heavy Menstrual Bleeding (HMB) Measured by Menstrual Bleeding Questionnaire (MBQ)
timeFrame: Up to 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: IQVIA RDS, Inc.
state: North Carolina
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: