Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03271489 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 478
- Enrollment target
NCT03271489: Completed Phase 3 study, sponsored by AbbVie.
NCT03271489 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 478 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03271489, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
Study Summary
This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.
Primary Outcome
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. AEs during the 12-month DB period were defined as any AEs with onset on/after first dose of study drug during the DB period and no more than 30 days after the last dose of study drug for participants who discontinued early during the DB period, or until the first dose
Interventions
- DRUG Elagolix
- DRUG Estradiol /norethindrone acetate (E2/NETA)
- OTHER E2/NETA Placebo
- OTHER Elagolix Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2017-09-13 |
| Est. Completion | 2024-06-28 |
| Phase | Phase 3 |
What the finished NCT03271489 record still lists
NCT03271489 is an interventional study that assigns participants to a tested intervention. The registered 478 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 4 interventions - of which Elagolix is the first listed.
NCT03271489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03271489 about?
NCT03271489 is a clinical study titled "Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women". This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study was double-blind (DB) during the first 12 months ...
What is the current status of trial NCT03271489?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2017-09-13. Estimated completion is 2024-06-28.
What interventions are being tested in trial NCT03271489?
The interventions under investigation include: Elagolix (DRUG), Estradiol /norethindrone acetate (E2/NETA) (DRUG), E2/NETA Placebo (OTHER), Elagolix Placebo (OTHER).
Who is sponsoring clinical trial NCT03271489?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03271489's enrollment target sits among peer trials
478 805th of 2000 higher than 1,194 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05446272 · 478 participants · NA
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
- NCT06172296 · 478 participants · Phase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
- NCT04221542 · 479 participants · Phase 1
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer
- NCT03911700 · 477 participants · NA
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI