Trial · NCT02925494
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT02925494, Phase 3, Completed, AbbVie; results first posted 2020-06-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids. Trials, record NCT02925494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02925494
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
- NCT number
- NCT02925494
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 433 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Uterine Fibroids, Heavy Menstrual Bleeding
- Interventions
- Estradiol/Norethindrone Acetate, Elagolix
- First posted
- 2016-10-06
- Last updated
- 2021-07-13
- Results first posted
- 2020-06-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Meeting the Criteria for Responder | From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study) | Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and * ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not. |
| Secondary | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6) | Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL. |
| Secondary | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6) | Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL. |
| Secondary | Percentage of Participants With Suppression of Bleeding at the Final Month | Final Month of Treatment Period (up through Month 6) | Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11. |
| Secondary | Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period | Month 6 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Meeting the Criteria for Responder | From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study) | All participants who received at least 1 dose of study drug and had an assessment. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6) | All participants who received at least 1 dose of study drug and had an assessment at given time point. | mL | MEAN |
| SECONDARY | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6) | All participants who received at least 1 dose of study drug and had an assessment at given time point. | percentage change | MEAN |
| SECONDARY | Percentage of Participants With Suppression of Bleeding at the Final Month | Final Month of Treatment Period (up through Month 6) | All participants who received at least 1 dose of study drug and had an assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period | Month 6 | All participants who received at least 1 dose of study drug, had a baseline hemoglobin concentration of \<= 10.5 g/dL and had an assessment. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Meeting the Criteria for Responder | Placebo->Elagolix | 85.7 | percentage of participants | ||
| Percentage of Participants Meeting the Criteria for Responder | Placebo->Elagolix + E2/NETA | 66.7 | percentage of participants | ||
| Percentage of Participants Meeting the Criteria for Responder | Elagolix->Elagolix | 89.4 | percentage of participants | ||
| Percentage of Participants Meeting the Criteria for Responder | Elagolix + E2/NETA->Elagolix + E2/NETA | 87.9 | percentage of participants | ||
| Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Placebo->Elagolix | Study Day 1 to 28 | -151.7 | Standard Deviation 184.76 | mL |
| Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Placebo->Elagolix + E2/NETA | Study Day 1 to 28 | -61.7 | Standard Deviation 212.01 | mL |
| Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Elagolix->Elagolix | Study Day 1 to 28 | -253.4 | Standard Deviation 190.07 | mL |
| Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Elagolix + E2/NETA->Elagolix + E2/NETA | Study Day 1 to 28 | -186.5 | Standard Deviation 164.38 | mL |
| Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Placebo->Elagolix | Study Day 29 to 56 | -210.9 | Standard Deviation 234.01 | mL |
| Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Placebo->Elagolix + E2/NETA | Study Day 29 to 56 | -203.1 | Standard Deviation 188.15 | mL |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Placebo->Elagolix | 59 | |
| Treatment Period | STARTED | Placebo->Elagolix + E2/NETA | 58 | |
| Treatment Period | STARTED | Elagolix->Elagolix | 98 | |
| Treatment Period | STARTED | Elagolix + E2/NETA->Elagolix + E2/NETA | 218 | |
| Treatment Period | COMPLETED | Placebo->Elagolix | 50 | |
| Treatment Period | COMPLETED | Placebo->Elagolix + E2/NETA | 43 | |
| Treatment Period | COMPLETED | Elagolix->Elagolix | 79 | |
| Treatment Period | COMPLETED | Elagolix + E2/NETA->Elagolix + E2/NETA | 182 | |
| Treatment Period | NOT COMPLETED | Placebo->Elagolix | 9 | |
| Treatment Period | NOT COMPLETED | Placebo->Elagolix + E2/NETA | 15 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events112
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo->Elagolix | 0 | 59 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo->Elagolix + E2/NETA | 3 | 58 | 3 |
| other | ANAEMIA | Blood and lymphatic system disorders | Elagolix->Elagolix | 0 | 98 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Elagolix + E2/NETA->Elagolix + E2/NETA | 2 | 218 | 2 |
| other | NAUSEA | Gastrointestinal disorders | Placebo->Elagolix | 5 | 59 | 5 |
| other | NAUSEA | Gastrointestinal disorders | Placebo->Elagolix + E2/NETA | 3 | 58 | 3 |
| other | NAUSEA | Gastrointestinal disorders | Elagolix->Elagolix | 2 | 98 | 2 |
| other | NAUSEA | Gastrointestinal disorders | Elagolix + E2/NETA->Elagolix + E2/NETA | 9 | 218 | 10 |
| other | NASOPHARYNGITIS | Infections and infestations | Placebo->Elagolix | 1 | 59 | 2 |
| other | NASOPHARYNGITIS | Infections and infestations | Placebo->Elagolix + E2/NETA | 1 | 58 | 1 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo->Elagolix | 0 | 59 |
| Total, all-cause mortality | Placebo->Elagolix + E2/NETA | 1 | 58 |
| Total, all-cause mortality | Elagolix->Elagolix | 0 | 98 |
| Total, all-cause mortality | Elagolix + E2/NETA->Elagolix + E2/NETA | 0 | 218 |
| Total, other adverse events | Placebo->Elagolix | 38 | 59 |
| Total, other adverse events | Placebo->Elagolix + E2/NETA | 26 | 58 |
| Total, other adverse events | Elagolix->Elagolix | 25 | 98 |
| Total, other adverse events | Elagolix + E2/NETA->Elagolix + E2/NETA | 50 | 218 |
| Total, serious adverse events | Placebo->Elagolix | 1 | 59 |
| Total, serious adverse events | Placebo->Elagolix + E2/NETA | 3 | 58 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02925494
GET https://conductscience.org/api/trials/v1/NCT02925494/results?page=2