Heavy Menstrual BleedingREACHNCT05026502
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
An observational study of Heavy Menstrual Bleeding and Uterine Fibroids, run by AbbVie at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding, Uterine Fibroids
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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)
- Medical subject headings
- Menorrhagia, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Being Treated With Elagolix + E2/NETA | Participants will receive Elagolix with Estradiol/Norethindrone Acetate per Standard of Care, as prescribed by their physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start5 Oct 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026502
- Sponsor's protocol ID
- P20-296
- Acronym
- REACH
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05026502
- Acronym / sponsor ID
- REACH / P20-296
- Conditions
- Heavy Menstrual Bleeding, Uterine Fibroids
- Keywords
- Elagolix, Estradiol/Norethindrone Acetate (E2/NETA), Oriahnn, ABT-620, Heavy Menstrual Bleeding (HMB), Uterine Fibroids (UF)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 23 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Being Treated With Elagolix + E2/NETA | – | –Participants will receive Elagolix with Estradiol/Norethindrone Acetate per Standard of Care, as prescribed by their physicians. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- Participants that report they are pregnant or planning to become pregnant in next 6 months.
- Participants reporting a surgical history of:
- Participants who have initiated elagolix + E2/NETA more than 30 days ago.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline in Self-Reported Heavy Menstrual Bleeding (HMB) Measured by Menstrual Bleeding Questionnaire (MBQ)
Time frame: 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.
Results and safety
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heavy Menstrual Bleeding and Uterine Fibroids, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Self-Reported Heavy Menstrual Bleeding (HMB) Measured by Menstrual Bleeding Questionnaire (MBQ) (time frame: Up to 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.