REACH: Observational 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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05026502

Collaborator

(none)

200

Enrollment

Location

10.8

Anticipated Duration (Months)

18.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heavy Menstrual Bleeding Uterine Fibroids

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Oct 5, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Participants Being Treated With Elagolix + E2/NETA Participants will receive Elagolix with Estradiol/Norethindrone Acetate per Standard of Care, as prescribed by their physicians.

Outcome Measures

Primary Outcome Measures

Change From Baseline in Self-Reported Heavy Menstrual Bleeding (HMB) Measured by Menstrual Bleeding Questionnaire (MBQ) [Up to 3 Months]
MBQ is a self-reported questionnaire that measures impact of HMB with 20 items and includes perception of heaviness of bleeding, bleeding pattern, pain, and impact of symptoms including social embarrassment, fear of social embarrassment, and behavioral changes to avoid social embarrassment. Sum responses to obtain a total score and multiply score by 1.32 to scale. Zero, least impact possible; 100, worst impact possible.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 51 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.