Trial · NCT02691494
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
NCT02691494, Phase 3, Completed, AbbVie; results first posted 2020-06-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study). Trials, record NCT02691494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02691494
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
- NCT number
- NCT02691494
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 378 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Uterine Fibroids, Heavy Menstrual Bleeding
- Interventions
- Elagolix, Placebo for Estradiol/Norethindrone Acetate, Estradiol/Norethindrone Acetate, Placebo for Elagolix
- First posted
- 2016-02-25
- Last updated
- 2021-07-13
- Results first posted
- 2020-06-30
Source ClinicalTrials.gov
Registered outcomes7
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 | Final Month (the last 28 days prior to and including the Reference Day), up to Month 6 | 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 Reference Day, which is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on 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 to the Final Month | Baseline and Final Month (the last 28 days prior to and including the Reference Day), up to Month 6 | Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, 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. The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date. |
| Secondary | Percentage of Participants With Suppression of Bleeding at the Final Month | Final Month (the last 28 days prior to and including the Reference Day), up to 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. The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date. |
| Secondary | Change From Baseline in MBL Volume to Month 6 | Month 0 (Baseline), Month 6 | Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, 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 | Change From Baseline in MBL Volume to Month 3 | Month 0 (Baseline), Month 3 | Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, 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 Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6 | Month 0 (Baseline), Month 6 | |
| Secondary | Change From Baseline in MBL Volume to Month 1 | Month 0 (Baseline), Month 1 | Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, 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. |
Source ClinicalTrials.gov
Outcomes7
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 | Final Month (the last 28 days prior to and including the Reference Day), up to Month 6 | All randomized and treated participants. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in MBL Volume to the Final Month | Baseline and Final Month (the last 28 days prior to and including the Reference Day), up to Month 6 | All randomized and treated participants. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Suppression of Bleeding at the Final Month | Final Month (the last 28 days prior to and including the Reference Day), up to Month 6 | All randomized and treated participants with an assessment | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in MBL Volume to Month 6 | Month 0 (Baseline), Month 6 | All randomized and treated participants with an assessment at given time point. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in MBL Volume to Month 3 | Month 0 (Baseline), Month 3 | All randomized and treated participants with an assessment at given time point. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6 | Month 0 (Baseline), Month 6 | All randomized and treated participants with baseline hemoglobin \<= 10.5 g/dL and an assessment at Month 6. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in MBL Volume to Month 1 | Month 0 (Baseline), Month 1 | All randomized and treated participants with an assessment at given time point. | mL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group21
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 | 10.5 | percentage of participants | ||
| Percentage of Participants Meeting the Criteria for Responder | Elagolix | 76.9 | percentage of participants | ||
| Percentage of Participants Meeting the Criteria for Responder | Elagolix + E2/NETA | 76.5 | percentage of participants | ||
| Change From Baseline in MBL Volume to the Final Month | Placebo | -4.3 | Standard Error 15.44 | mL | |
| Change From Baseline in MBL Volume to the Final Month | Elagolix | -198.8 | Standard Error 15.44 | mL | |
| Change From Baseline in MBL Volume to the Final Month | Elagolix + E2/NETA | -168.8 | Standard Error 10.72 | mL | |
| Percentage of Participants With Suppression of Bleeding at the Final Month | Placebo | 4.7 | percentage of participants | ||
| Percentage of Participants With Suppression of Bleeding at the Final Month | Elagolix | 88.9 | percentage of participants | ||
| Percentage of Participants With Suppression of Bleeding at the Final Month | Elagolix + E2/NETA | 61.0 | percentage of participants | ||
| Change From Baseline in MBL Volume to Month 6 | Placebo | 28.5 | Standard Error 16.68 | mL |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Placebo | 94 | |
| Treatment Period | STARTED | Elagolix | 95 | |
| Treatment Period | STARTED | Elagolix + E2/NETA | 189 | |
| Treatment Period | COMPLETED | Placebo | 72 | |
| Treatment Period | COMPLETED | Elagolix | 69 | |
| Treatment Period | COMPLETED | Elagolix + E2/NETA | 148 | |
| Treatment Period | NOT COMPLETED | Placebo | 22 | |
| Treatment Period | NOT COMPLETED | Elagolix | 26 | |
| Treatment Period | NOT COMPLETED | Elagolix + E2/NETA | 41 | |
| Post-Treatment Follow-Up Period | STARTED | Placebo | 14 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events72
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 | NAUSEA | Gastrointestinal disorders | Placebo | 9 | 94 | 11 |
| other | NAUSEA | Gastrointestinal disorders | Elagolix | 4 | 95 | 4 |
| other | NAUSEA | Gastrointestinal disorders | Elagolix + E2-NETA | 14 | 189 | 15 |
| other | FATIGUE | General disorders | Placebo | 5 | 94 | 5 |
| other | FATIGUE | General disorders | Elagolix | 3 | 95 | 3 |
| other | FATIGUE | General disorders | Elagolix + E2-NETA | 10 | 189 | 10 |
| other | NASOPHARYNGITIS | Infections and infestations | Placebo | 8 | 94 | 9 |
| other | NASOPHARYNGITIS | Infections and infestations | Elagolix | 4 | 95 | 4 |
| other | NASOPHARYNGITIS | Infections and infestations | Elagolix + E2-NETA | 10 | 189 | 11 |
| other | URINARY TRACT INFECTION | Infections and infestations | Placebo | 5 | 94 | 6 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 94 |
| Total, all-cause mortality | Elagolix | 0 | 95 |
| Total, all-cause mortality | Elagolix + E2-NETA | 0 | 189 |
| Total, other adverse events | Placebo | 34 | 94 |
| Total, other adverse events | Elagolix | 58 | 95 |
| Total, other adverse events | Elagolix + E2-NETA | 80 | 189 |
| Total, serious adverse events | Placebo | 1 | 94 |
| Total, serious adverse events | Elagolix | 4 | 95 |
| Total, serious adverse events | Elagolix + E2-NETA | 7 | 189 |
Source ClinicalTrials.gov
Papers6
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/NCT02691494
GET https://conductscience.org/api/trials/v1/NCT02691494/results?page=2