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NCT05026502: REACH
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
trial in Heavy Menstrual Bleeding in 23 participants. Terminated before completion.
30 August 2022
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 23 |
| Start date | 5 October 2021 |
| Primary completion | 30 August 2022 |
| Estimated completion | 30 August 2022 |
| Sites | 1 location across United States |
Conditions studied
- Heavy Menstrual Bleeding — all drugs for Heavy Menstrual Bleeding →
- Uterine Fibroids — all drugs for Uterine Fibroids →
Sponsor
AbbVie — full company profile →
Who can join
Adults 18 to 51, female only, with Heavy Menstrual Bleeding or Uterine Fibroids. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05026502
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heavy Menstrual Bleeding
Currently open trials in the same condition.
- NCT07326722 — Delivering tAN to Reduce HMB: The LUNA Study · NA · recruiting
- NCT06634719 — Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB) · NA · recruiting
- NCT06671548 — Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids · Phase 3 · recruiting
- NCT05922657 — A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device · recruiting
- NCT06921629 — Menstrual Complaints in Adolescents and Adults · active not recruiting
Other AbbVie trials
Trials by the same sponsor.
- NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
- NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
- NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
- NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
- NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05026502 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AbbVie
- Last refreshed: 14 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05026502.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing