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

NCT05026502 | Terminated

• 1 other identifier: P20-296
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Heavy Menstrual Bleeding; Uterine Fibroids

Keywords

Elagolix; Estradiol/Norethindrone Acetate (E2/NETA); Oriahnn; ABT-620; Heavy Menstrual Bleeding (HMB); Uterine Fibroids (UF)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Self-Reported Heavy Menstrual Bleeding (HMB) Measured by Menstrual Bleeding Questionnaire (MBQ)

  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.

  Up to 3 Months

Study Arms (1)

Participants Being Treated With Elagolix + E2/NETA

Participants will receive Elagolix with Estradiol/Norethindrone Acetate per Standard of Care, as prescribed by their physicians.

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

IQVIA RDS, Inc.

Durham, North Carolina, 27703, United States

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Menorrhagia; Leiomyoma

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 30, 2021
• Study Start: October 5, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

US (1)