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

Uterine Fibroids Clinical Trial

— REACH  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05026502
• Other study ID #: P20-296
• Status: Terminated
• Start date: October 5, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heavy Menstrual Bleeding
• Hemorrhage
• Leiomyoma
• Menorrhagia
• Uterine Fibroids

Locations

Country	Name	City	State
United States	IQVIA RDS, Inc.	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   clinical study report synopsis