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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-05

Study Completion Date

2022-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

NCT01817530

Heavy Uterine Bleeding Uterine Fibroids

COMPLETED PHASE2

A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

NCT03886220

Uterine Fibroids

COMPLETED PHASE4

Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L

NCT04856306

Heavy Menstrual Bleeding Fibroid Uterus

UNKNOWN

Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

NCT01441635

Heavy Uterine Bleeding Uterine Fibroids

COMPLETED PHASE2

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

NCT03070951

Uterine Fibroids Heavy Menstrual Bleeding

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heavy Menstrual Bleeding Uterine Fibroids

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants Being Treated With Elagolix + E2/NETA

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No