Trial · NCT01817530
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
NCT01817530, Phase 2, Completed, AbbVie; results first posted 2020-07-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF). Trials, record NCT01817530. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01817530
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
- NCT number
- NCT01817530
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 571 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Heavy Uterine Bleeding, Uterine Fibroids
- Interventions
- Elagolix placebo, Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate, 1 mg estradiol / 0.5 mg norethindrone acetate, E2/NETA placebo
- First posted
- 2013-03-25
- Last updated
- 2020-07-21
- Other registries' IDs
- eudract:2013-000082-37
- Results first posted
- 2020-07-21
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Baseline, Final Month (last 28 days of treatment) | The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of \< 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period. |
| Secondary | Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment | Baseline, second last 28 days of treatment (last 56 to 29 days of treatment) | The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume \< 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 56 to 29 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period. |
| Secondary | Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment | Baseline, third last 28 days of treatment (last 84 to 57 days of treatment) | The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume \< 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 84 to 57 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period. |
| Secondary | Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month | Final Month (last 28 days of treatment) | Percentage of participants who achieved an MBL volume of \< 80 mL at the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period. |
| Secondary | Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Baseline, Final Month (last 28 days of treatment) | Percentage of participants with a \>= 50% reduction from baseline in MBL to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period. |
| Secondary | Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment | Last 56 days of treatment (after 10 days from first dose date) | Amenorrhea is defined as having 0 days of bleeding or spotting based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding or spotting, based on imputed electronic diary data during the last 56 days of treatment. Participants needed to have at least 66 days on treatment. |
| Secondary | Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment | Last 56 days of treatment (after 10 days from first dose date) | Suppression of bleeding is defined as having 0 days of bleeding based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding (spotting is allowed) based on imputed electronic diary data during the last 56 days of treatment. |
| Secondary | Mean Change in the Number of Bleeding Days From Baseline to Month 6 | Baseline, Month 6 | The number of days with any bleeding including spotting was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug. |
| Secondary | Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6 | Baseline, Month 6 | The number of days with heavy bleeding (either heavy or very heavy/gushing bleeding) was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug. |
| Secondary | Change in Bleeding Severity Scores From Baseline at the Final Month | Baseline, Final Month (last 28 days of treatment) | The average bleeding score was calculated for each 28-day interval starting on Day 29 using data collected on daily bleeding diary using the Mansfield-Voda-Jorgenson (MVJ) Menstrual Bleeding Scale (1=spotting, 2 = very light bleeding, 3 = light bleeding, 4 = moderate bleeding, 5 = heavy bleeding, 6 = very heavy/gushing bleeding). Baseline is defined as the last 28 days prior to the first day of study drug. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Baseline, Final Month (last 28 days of treatment) | Modified Intent-to-Treat (ITT): randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 28 days of treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment | Baseline, second last 28 days of treatment (last 56 to 29 days of treatment) | Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 56 days of treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment | Baseline, third last 28 days of treatment (last 84 to 57 days of treatment) | Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 84 days of treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month | Final Month (last 28 days of treatment) | Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 28 days of treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Baseline, Final Month (last 28 days of treatment) | Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 28 days of treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment | Last 56 days of treatment (after 10 days from first dose date) | Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 66 days of treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment | Last 56 days of treatment (after 10 days from first dose date) | Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 66 days of treatment. | percentage of participants | NUMBER |
| SECONDARY | Mean Change in the Number of Bleeding Days From Baseline to Month 6 | Baseline, Month 6 | Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and Month 6. | days | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6 | Baseline, Month 6 | Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and Month 6. | days | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Bleeding Severity Scores From Baseline at the Final Month | Baseline, Final Month (last 28 days of treatment) | Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and final month. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group336
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Cohort 1: Placebo | 26.56 | percentage of participants | ||
| Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Cohort 1: Elagolix 300 mg BID | 91.94 | percentage of participants | ||
| Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 85.25 | percentage of participants | ||
| Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 79.03 | percentage of participants | ||
| Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Cohort 2: Placebo | 31.58 | percentage of participants | ||
| Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Cohort 2: Elagolix 600 mg QD | 90.14 | percentage of participants | ||
| Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 72.6 | percentage of participants | ||
| Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month | Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 81.58 | percentage of participants | ||
| Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment | Cohort 1: Placebo | 11.29 | percentage of participants | ||
| Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment | Cohort 1: Elagolix 300 mg BID | 94.83 | percentage of participants |
1 to 10 of 336Source ClinicalTrials.gov
See all 336 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Placebo | 65 | |
| Overall Study | STARTED | Cohort 1: Elagolix 300 mg BID | 65 | |
| Overall Study | STARTED | Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 64 | |
| Overall Study | STARTED | Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 65 | |
| Overall Study | STARTED | Cohort 2: Placebo | 78 | |
| Overall Study | STARTED | Cohort 2: Elagolix 600 mg QD | 77 | |
| Overall Study | STARTED | Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 76 | |
| Overall Study | STARTED | Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 77 | |
| Overall Study | COMPLETED | Cohort 1: Placebo | 50 | |
| Overall Study | COMPLETED | Cohort 1: Elagolix 300 mg BID | 52 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events472
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 | Cohort 1: Placebo | 6 | 65 | 6 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 1: Elagolix 300 mg BID | 1 | 65 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 2 | 64 | 2 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 2 | 65 | 2 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 2: Placebo | 6 | 78 | 6 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 2: Elagolix 600 mg QD | 3 | 77 | 3 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 6 | 76 | 6 |
| other | ANAEMIA | Blood and lymphatic system disorders | Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 4 | 77 | 4 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Cohort 1: Placebo | 1 | 65 | 1 |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | Cohort 1: Elagolix 300 mg BID | 1 | 65 | 1 |
1 to 10 of 472Source ClinicalTrials.gov
See all 472 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Placebo | 0 | 65 |
| Total, all-cause mortality | Cohort 1: Elagolix 300 mg BID | 0 | 65 |
| Total, all-cause mortality | Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 0 | 64 |
| Total, all-cause mortality | Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 0 | 65 |
| Total, all-cause mortality | Cohort 2: Placebo | 0 | 78 |
| Total, all-cause mortality | Cohort 2: Elagolix 600 mg QD | 0 | 77 |
| Total, all-cause mortality | Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 0 | 76 |
| Total, all-cause mortality | Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 0 | 77 |
| Total, other adverse events | Cohort 1: Placebo | 33 | 65 |
| Total, other adverse events | Cohort 1: Elagolix 300 mg BID | 45 | 65 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30303923 | DERIVED |
Source PubMed
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01817530
GET https://conductscience.org/api/trials/v1/NCT01817530/results?page=2