Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

AbbVie571 enrolled

Overview

This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

571

Conditions

Heavy Uterine Bleeding Uterine Fibroids

Interventions

Elagolix placeboOTHER

oral coated tablet

ElagolixDRUG

oral coated tablet

0.5 mg estradiol / 0.1 mg norethindrone acetateDRUG

oral hard capsule

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 51 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is pre-menopausal female 18 to 51 years of age at Screening. * Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound. * Subject has heavy uterine bleeding associated with uterine fibroids. Exclusion Criteria: * Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening. * Subject has a history of osteoporosis or other metabolic bone disease. * Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide. * Subject has a history of clinically significant condition(s) including but not limited to: \* Symptomatic Endometriosis \* Epilepsy or seizures \* Type 1 diabetes \* Chronic kidney disease \* Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline, Final Month (last 28 days of treatment)

Secondary Outcomes

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

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.

Time frame: Baseline, second last 28 days of treatment (last 56 to 29 days of treatment)

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

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.

Time frame: Baseline, third last 28 days of treatment (last 84 to 57 days of treatment)

Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month

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.

Data from ClinicalTrials.gov

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E2/NETA placeboDRUG

oral hard capsule

Time frame: Final Month (last 28 days of treatment)

Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month

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.

Time frame: Baseline, Final Month (last 28 days of treatment)

Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment

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.

Time frame: Last 56 days of treatment (after 10 days from first dose date)

Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment

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.

Time frame: Last 56 days of treatment (after 10 days from first dose date)

Mean Change in the Number of Bleeding Days From Baseline to 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.

Time frame: Baseline, Month 6

Mean Change in the Number of Heavy Bleeding Days From Baseline to 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.

Time frame: Baseline, Month 6

Change in Bleeding Severity Scores From Baseline at the Final Month

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.

Time frame: Baseline, Final Month (last 28 days of treatment)

Mean Change in Hemoglobin Concentration From Baseline to Final Visit

Baseline is defined as the last measurement prior to the first dose of study drug.

Time frame: Baseline, Final Visit during treatment period (Month 6 or early termination)

Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit

Volume of the total fibroid volume (3 largest fibroids), as measured by transvaginal ultrasound, or transabdominal ultrasound.