A Phase 3 interventional study of Elagolix and Estradiol /norethindrone acetate (E2/NETA) in Heavy Menstrual Bleeding and Uterine Fibroids, sponsored by AbbVie. Completed at 157 sites in 2 countries. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
Among 85 studies in Menorrhagia with a site in United States — 8 open to participants now, 10 under way, none of them phase 3. Menorrhagia · United States.
Among the 85 studies in Menorrhagia with a site in United States, this one is the 6th largest by enrollment of the 71 interventional ones, is one of 8 that started in 2017, is one of 22 in phase 3, and was the 54th registered.
206 studies on the registry are indexed under Menorrhagia; 35 are open to participants now.
This study's enrollment of 478 is above the median of 95 across 149 interventional studies indexed under Menorrhagia.
Browse Menorrhagia studies →8 of the 85 studies in Menorrhagia with a site in United States are open now, in 6 countries. Each count lists the studies.
Of the 23 Menorrhagia studies recruiting now, 4 (17%) set no upper age limit and 19 (83%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 50 Years · female · no healthy volunteers.
The full table on the hub →85 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 8 started in 2017.
Median enrollment 82 across the 71 interventional studies, 256 across the 14 observational. Of the 66 that completed or were terminated, 40 (61%) have results posted.
43 of 85 have an industry lead sponsor. The 10 most frequent:
AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
AbbVie has 8 studies filed under Menorrhagia — fewer than ten, so there is no comparison to draw.
3 of the studies in Menorrhagia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT07575308Alnylam PharmaceuticalsHMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB | 2027-06-30 |
| NCT07326722Spark Biomedical, Inc.Delivering tAN to Reduce HMB: The LUNA Study | 2027-08-31 |
Among the 85 studies in Menorrhagia with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
478 participants were randomly assigned at a ratio of 2:1 to the following treatment groups:
This study was double-blinded during the first 12 months and open-label for the next 36 months. Participants entered up to 12 months of PTFU after completing treatment Month 48 (or at any time a participant prematurely discontinued treatment).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Elagolix · Drug: Estradiol /norethindrone acetate (E2/NETA)
Other: E2/NETA Placebo · Other: Elagolix Placebo
Film-coated 300 mg tablets
Drug pages: Estradiol · Norethindrone Acetate
Estradiol 1 mg/norethindrone acetate 0.5 mg capsules
Placebo capsules
Film-coated placebo tablets
Number of Participants With Adverse Events (AEs)
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 of study drug in the OL period for participants who entered the OL Treatment Period. AEs during the OL period were defined as AEs with onset on/after first dose of study drug during the OL period and no more than 30 days after the last dose of study drug. During the post-treatment follow-up (PTFU) period, adverse events were collected from 30 days post-last dose until end of study. Safety reporting during the PTFU period included AESIs. Other AEs may have also been reported.
Time frame: Baseline to 60 months
Bone Mineral Density (BMD) Recovery After up to 48 Months of Treatment
Percent Recovery of BMD after 6 and 12 months of post-treatment follow-up (PTFU) for Spine, Total Hip, and Femoral Neck. BMD assessments were measured by dual X-ray absorptiometry (DXA). Analysis excludes participants who switched machine manufacturer type. Percent recovery is defined as 100\*(% change from Baseline to final on-treatment assessment - % change from Baseline to post-treatment visit) / (% change from Baseline to final on treatment assessment) and is defined only for subjects with BMD decrease at final on-treatment assessment.
Time frame: Baseline through Month 60
A total of 478 participants were enrolled across the United States and Puerto Rico.
| Milestone | Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Placebo |
|---|---|---|
| Started | 319 | 159 |
| Completed | 319 | 159 |
| Not completed | 0 | 0 |
| Milestone | Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Placebo |
|---|---|---|
| Started | 319 | 159 |
| Completed | 283 | 135 |
| Not completed | 36 | 24 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Withdrawal by subject | 13 | 10 |
| Withdrew: Lost to follow-up | 9 | 9 |
| Withdrew: Requires surgery or invasive intervention for treatment of uterine fibroids | 3 | 2 |
| Withdrew: Non-compliance with study procedures | 0 | 1 |
| Withdrew: Other | 6 | 1 |
| Withdrew: Missing | 1 | 0 |
| Milestone | Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Placebo |
|---|---|---|
| Started | 193 | 84 |
| Completed | 159 | 68 |
| Not completed | 34 | 16 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Withdrawal by subject | 14 | 8 |
| Withdrew: Lost to follow-up | 10 | 5 |
| Withdrew: Non-compliance with study procedures | 4 | 1 |
| Withdrew: No specified | 2 | 2 |
| Withdrew: Missing | 2 | 0 |
| Milestone | Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Placebo |
|---|---|---|
| Started | 319 | 159 |
| Completed | 189 | 86 |
| Not completed | 130 | 73 |
| Withdrew: Adverse event | 16 | 6 |
| Withdrew: Withdrawal by subject | 40 | 26 |
| Withdrew: Lost to follow-up | 35 | 24 |
| Withdrew: Requires surgery or invasive intervention for treatment of uterine fibroids | 5 | 3 |
| Withdrew: Non-compliance with study procedures | 9 | 2 |
| Withdrew: Covid-19 logistical restrictions | 1 | 0 |
| Withdrew: Other | 21 | 10 |
| Withdrew: Missing | 3 | 2 |
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 of study drug in the OL period for participants who entered the OL Treatment Period. AEs during the OL period were defined as AEs with onset on/after first dose of study drug during the OL period and no more than 30 days after the last dose of study drug. During the post-treatment follow-up (PTFU) period, adverse events were collected from 30 days post-last dose until end of study. Safety reporting during the PTFU period included AESIs. Other AEs may have also been reported.
| Participants | Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Placebo |
|---|---|---|
| Double-blind Period | 203 | 83 |
| Open-label Period | 124 | 59 |
| Post-treatment Follow-up Period | 22 | 6 |
Percent Recovery of BMD after 6 and 12 months of post-treatment follow-up (PTFU) for Spine, Total Hip, and Femoral Neck. BMD assessments were measured by dual X-ray absorptiometry (DXA). Analysis excludes participants who switched machine manufacturer type. Percent recovery is defined as 100\*(% change from Baseline to final on-treatment assessment - % change from Baseline to post-treatment visit) / (% change from Baseline to final on treatment assessment) and is defined only for subjects with BMD decrease at final on-treatment assessment.
| Participants | Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Placebo |
|---|---|---|
| Spine (6 months PTFU) — < 0% Recovery | 24 | 10 |
| Spine (6 months PTFU) — 0% - 25% Recovery | 8 | 2 |
| Spine (6 months PTFU) — > 25% - 50% Recovery | 3 | 2 |
| Spine (6 months PTFU) — > 50% - 75% Recovery | 5 | 2 |
| Spine (6 months PTFU) — > 75% - 100% Recovery | 5 | 1 |
| Spine (6 months PTFU) — > 100% Recovery | 9 | 2 |
| Spine (12 months PTFU) — < 0% Recovery | 23 | 10 |
| Spine (12 months PTFU) — 0% - 25% Recovery | 3 | 2 |
| Spine (12 months PTFU) — > 25% - 50% Recovery | 5 | 1 |
| Spine (12 months PTFU) — > 50% - 75% Recovery | 9 | 2 |
| Spine (12 months PTFU) — > 75% - 100% Recovery | 5 | 0 |
| Spine (12 months PTFU) — > 100% Recovery | 20 | 7 |
| Total Hip (6 months PTFU) — < 0% Recovery | 20 | 10 |
| Total Hip (6 months PTFU) — 0% - 25% Recovery | 5 | 1 |
| Total Hip (6 months PTFU) — > 25% - 50% Recovery | 5 | 4 |
| Total Hip (6 months PTFU) — > 50% - 75% Recovery | 7 | 1 |
| Total Hip (6 months PTFU) — > 75% - 100% Recovery | 1 | 0 |
| Total Hip (6 months PTFU) — > 100% Recovery | 13 | 1 |
| Total Hip (12 months PTFU) — < 0% Recovery | 22 | 12 |
| Total Hip (12 months PTFU) — 0% - 25% Recovery | 11 | 1 |
| Total Hip (12 months PTFU) — > 25% - 50% Recovery | 7 | 1 |
| Total Hip (12 months PTFU) — > 50% - 75% Recovery | 6 | 2 |
| Total Hip (12 months PTFU) — > 75% - 100% Recovery | 5 | 0 |
| Total Hip (12 months PTFU) — > 100% Recovery | 15 | 3 |
| Femoral Neck (6 months PTFU) — < 0% Recovery | 22 | 10 |
| Femoral Neck (6 months PTFU) — 0% - 25% Recovery | 5 | 2 |
| Femoral Neck (6 months PTFU) — > 25% - 50% Recovery | 8 | 1 |
| Femoral Neck (6 months PTFU) — > 50% - 75% Recovery | 5 | 4 |
| Femoral Neck (6 months PTFU) — > 75% - 100% Recovery | 4 | 1 |
| Femoral Neck (6 months PTFU) — > 100% Recovery | 7 | 2 |
| Femoral Neck (12 months PTFU) — < 0% Recovery | 18 | 10 |
| Femoral Neck (12 months PTFU) — 0% - 25% Recovery | 12 | 2 |
| Femoral Neck (12 months PTFU) — > 25% - 50% Recovery | 7 | 1 |
| Femoral Neck (12 months PTFU) — > 50% - 75% Recovery | 6 | 3 |
| Femoral Neck (12 months PTFU) — > 75% - 100% Recovery | 3 | 1 |
| Femoral Neck (12 months PTFU) — > 100% Recovery | 14 | 5 |
Collected over All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed for the screening period was: 106 days (PBO) and 113 days (ELA/E2-NETA); double blind period: 335 days (PBO) and 336 days (ELA/E2-NETA); open label period: 555 days (PBO to ELA/E2-NETA) and 681 days (ELA/E2-NETA to ELA/E2-NETA); long-term follow-up period: 197 days (PBO to ELA/E2-NETA) and 324 days (ELA/E2-NETA to ELA/E2-NETA).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Screening Placebo | 0/159 (0%) | 1/159 (0.6%) | 1/159 (0.6%) |
| Screening Elagolix E2/NETA | 0/319 (0%) | 3/319 (0.9%) | 0/319 (0%) |
| Double-Blind Placebo | 0/159 (0%) | 2/159 (1.3%) | 28/159 (17.6%) |
| Double-Blind Elagolix E2/NETA | 1/319 (0.3%) | 10/319 (3.1%) | 88/319 (27.6%) |
| Open Label Placebo to Elagolix E2/NETA | 0/84 (0%) | 7/84 (8.3%) | 41/84 (48.8%) |
| Open Label Elagolix E2 NETA to Elagolix E2/NETA | 0/193 (0%) | 9/193 (4.7%) | 65/193 (33.7%) |
| Follow-up: Placebo to Elagolix E2/NETA | 0/159 (0%) | 1/159 (0.6%) | 3/159 (1.9%) |
| Follow-up: Elagolix E2 NETA to Elagolix E2/NETA | 1/319 (0.3%) | 3/319 (0.9%) | 5/319 (1.6%) |
| Event | Screening Placebo | Screening Elagolix E2/NETA | Double-Blind Placebo | Double-Blind Elagolix E2/NETA | Open Label Placebo to Elagolix E2/NETA | Open Label Elagolix E2 NETA to Elagolix E2/NETA | Follow-up: Placebo to Elagolix E2/NETA | Follow-up: Elagolix E2 NETA to Elagolix E2/NETA |
|---|---|---|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTIONCardiac disorders | 0/159 | 0/319 | 0/159 | 0/319 | 2/84 | 0/193 | 0/159 | 0/319 |
| ANAEMIABlood and lymphatic system disorders | 1/159 | 1/319 | 2/159 | 1/319 | 0/84 | 0/193 | 0/159 | 1/319 |
| SPLENIC INFARCTIONBlood and lymphatic system disorders | 0/159 | 0/319 | 0/159 | 0/319 | 1/84 | 0/193 | 0/159 | 0/319 |
| CARDIOMYOPATHYCardiac disorders | 0/159 | 0/319 | 0/159 | 0/319 | 1/84 | 0/193 | 0/159 | 0/319 |
| NON-CARDIAC CHEST PAINGeneral disorders | 0/159 | 0/319 | 0/159 | 0/319 | 1/84 | 0/193 | 0/159 | 0/319 |
| COVID-19 PNEUMONIAInfections and infestations | 0/159 | 0/319 | 0/159 | 1/319 | 1/84 | 0/193 | 0/159 | 0/319 |
| BACK PAINMusculoskeletal and connective tissue disorders | 0/159 | 0/319 | 0/159 | 0/319 | 1/84 | 0/193 | 0/159 | 0/319 |
| ASTHMARespiratory, thoracic and mediastinal disorders | 0/159 | 0/319 | 0/159 | 0/319 | 1/84 | 0/193 | 0/159 | 0/319 |
| UTERINE LEIOMYOMANeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/159 | 0/319 | 0/159 | 2/319 | 0/84 | 0/193 | 1/159 | 1/319 |
| DEEP VEIN THROMBOSISVascular disorders | 0/159 | 0/319 | 1/159 | 0/319 | 0/84 | 0/193 | 0/159 | 0/319 |
| Event | Screening Placebo | Screening Elagolix E2/NETA | Double-Blind Placebo | Double-Blind Elagolix E2/NETA | Open Label Placebo to Elagolix E2/NETA | Open Label Elagolix E2 NETA to Elagolix E2/NETA | Follow-up: Placebo to Elagolix E2/NETA | Follow-up: Elagolix E2 NETA to Elagolix E2/NETA |
|---|---|---|---|---|---|---|---|---|
| BONE DENSITY DECREASEDInvestigations | 0/159 | 0/319 | 2/159 | 16/319 | 8/84 | 27/193 | 0/159 | 1/319 |
| COVID-19Infections and infestations | 0/159 | 0/319 | 1/159 | 1/319 | 11/84 | 24/193 | 0/159 | 0/319 |
| HOT FLUSHVascular disorders | 0/159 | 0/319 | 6/159 | 30/319 | 6/84 | 3/193 | 0/159 | 1/319 |
| HEAVY MENSTRUAL BLEEDINGReproductive system and breast disorders | 1/159 | 0/319 | 4/159 | 6/319 | 7/84 | 3/193 | 0/159 | 2/319 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 0/159 | 0/319 | 3/159 | 9/319 | 6/84 | 4/193 | 1/159 | 1/319 |
| TRICHOMONIASISInfections and infestations | 0/159 | 0/319 | 0/159 | 2/319 | 5/84 | 0/193 | 0/159 | 0/319 |
| HYPERTENSIONVascular disorders | 0/159 | 0/319 | 5/159 | 9/319 | 5/84 | 7/193 | 0/159 | 0/319 |
| VAGINAL HAEMORRHAGEReproductive system and breast disorders | 0/159 | 0/319 | 1/159 | 5/319 | 4/84 | 11/193 | 1/159 | 0/319 |
| HEADACHENervous system disorders | 0/159 | 0/319 | 6/159 | 17/319 | 4/84 | 3/193 | 1/159 | 0/319 |
| BACK PAINMusculoskeletal and connective tissue disorders | 0/159 | 0/319 | 8/159 | 12/319 | 3/84 | 1/193 | 1/159 | 0/319 |
Full Analysis Set
| Age, Continuous(Years) | Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Placebo | Total |
|---|---|---|---|
| Mean | 42.6 ± 5.07 | 41.7 ± 5.65 | 42.3 ± 5.28 |
| Sex: Female, Male(Participants) | Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Placebo | Total |
|---|---|---|---|
| Female | 319 | 159 | 478 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 77 | 31 | 108 |
| Not Hispanic or Latino | 242 | 128 | 370 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Elagolix Plus Estradiol (E2)/Norethindrone Acetate (NETA) | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 7 | 2 | 9 |
| Native Hawaiian or Other Pacific Islander | 3 | 3 | 6 |
| Black or African American | 171 | 99 | 270 |
| White | 128 | 51 | 179 |
| More than one race | 6 | 3 | 9 |
| Unknown or Not Reported | 2 | 1 | 3 |
Showing the first 100 of 157 sites across 2 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
Ran from Sep 2017 to primary completion in Jun 2024, 81 months.
Results were first posted in Jul 2025, 1 year after primary completion.
Of 17 phase 3 interventional studies under Menorrhagia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 35. This study's 81 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Elagolix · Estradiol · Norethindrone Acetate