Uterine Fibroids
Conditions
Keywords
Elagolix, ABT-620, Uterine Fibroids, Heavy Menstrual Bleeding (HMB)
Brief summary
The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.
Interventions
DRUGElagolix
Oral; Tablet
DRUGPlacebo
Oral; Tablet
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
No
Inclusion criteria
* Participant at the time of screening has a diagnosis of uterine fibroids documented by a pelvic ultrasound \[transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)\]. * Participant has HMB associated with uterine fibroids as evidenced by menstrual blood loss (MBL) \> 80 mL during 1 menses in screening as measured by the alkaline hematin method. * Participant has negative urine and/or serum pregnancy test in Washout (if applicable) and/or Screening and just prior to first dose. * Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.
Exclusion criteria
* Participant has screening pelvic ultrasound or saline infusion sonohysterography (SIS) or magnetic resonance imaging (MRI; if SIS is unevaluable), results that show a clinically significant gynecological disorder. * Participant has history of osteoporosis, osteopenia, or other metabolic bone disease. * Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis. * Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder). * Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the Final Month | From Month 0 (Baseline) to Final Month (up to Month 6) | Responders were defined as participants meeting the following 2 conditions: * menstrual blood loss (MBL) volume \< 80 mL at the Final Month (defined as the last 28 days prior to and including the last dose day), and * 50% or greater reduction in MBL volume from Baseline to the Final Month. Participants whose primary reason for prematurely discontinuing study drug was lack of efficacy, or requires surgery or invasive intervention for treatment of uterine fibroids were considered as non-responders. MBL was measured by the alkaline hematin method. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo QD | 28 |
| Elagolix 150 mg Elagolix 150 mg QD | 54 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Post-Treatment Follow-Up Period | Lost to Follow-up | 1 | 2 |
| Post-Treatment Follow-Up Period | Withdrawal by Subject | 1 | 0 |
| Treatment Period | Discontinued study drug during the treatment period | 5 | 12 |
Baseline characteristics
| Characteristic | Elagolix 150 mg | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 5.02 | 42.3 years STANDARD_DEVIATION 4.65 | 43.0 years STANDARD_DEVIATION 3.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 18 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 64 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 37 Participants | 54 Participants | 17 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 27 Participants | 11 Participants |
| Sex: Female, Male Female | 54 Participants | 82 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 54 |
| other Total, other adverse events | 2 / 28 | 11 / 54 |
| serious Total, serious adverse events | 2 / 28 | 0 / 54 |
Outcome results
Primary
Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the Final Month
Responders were defined as participants meeting the following 2 conditions: * menstrual blood loss (MBL) volume \< 80 mL at the Final Month (defined as the last 28 days prior to and including the last dose day), and * 50% or greater reduction in MBL volume from Baseline to the Final Month. Participants whose primary reason for prematurely discontinuing study drug was lack of efficacy, or requires surgery or invasive intervention for treatment of uterine fibroids were considered as non-responders. MBL was measured by the alkaline hematin method.
Time frame: From Month 0 (Baseline) to Final Month (up to Month 6)
Population: Full Analysis Set; multiple imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the Final Month | 23.3 percentage of participants |
| Elagolix 150 mg | Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the Final Month | 49.4 percentage of participants |
p-value: 0.03595% CI: [1.086, 9.546]Regression, Logistic