Efficacy and Safety of Elagolix in Combination With Estra... | NCT02691494

NCT02691494

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/ NETA) once daily (QD)	Drug: Placebo for Estradiol/Norethindrone Acetate Drug: Placebo for Elagolix
Elagolix	Experimental	Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD	Drug: Elagolix Drug: Placebo for Estradiol/Norethindrone Acetate
Elagolix + E2/NETA	Experimental	Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD	Drug: Elagolix Drug: Estradiol/Norethindrone Acetate

Name	Type	Description	Arm Group Labels	Other Names
Elagolix	Drug	Film-coated tablets	Elagolix Elagolix + E2/NETA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Meeting the Criteria for Responder	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.	Final Month (the last 28 days prior to and including the Reference Day), up to Month 6

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in MBL Volume to the Final Month	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.

Eligibility Module

Name	Affiliation	Role
AbbVie Inc.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Clinical Therapeutics, LLC /ID# 152258		Birmingham	Alabama	35235-3430	United States
Choice Research, LLC /ID# 150988

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39381651	Derived	Simon JA, Stewart EA, Jewell S, Li M, Snabes MC. Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials. F S Rep. 2024 Jun 14;5(3):285-295. doi: 10.1016/j.xfre.2024.06.002. eCollection 2024 Sep.
34878624

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Placebo for both elagolix BID and E2/NETA QD
FG001	Elagolix	Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 6, 2017	Jun 10, 2020

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo for both elagolix BID and E2/NETA QD
BG001	Elagolix	Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
BG002	Elagolix + E2/NETA	Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00042.5± 5.43 BG00142.2± 5.41 BG00242.5± 5.33 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00094 BG00195 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00011 BG00117 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Meeting the Criteria for Responder

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.

All randomized and treated participants.

Posted

Number

percentage of participants

Final Month (the last 28 days prior to and including the Reference Day), up to Month 6

ID	Title	Description
OG000	Placebo	Placebo for both elagolix BID and E2/NETA QD
OG001	Elagolix	Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
OG002	Elagolix + E2/NETA	Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD

Units	Counts
Participants	OG00094 OG00195 OG002189

Title

Denominators

Categories

Title	Measurements
	OG00010.5 OG00176.9 OG00276.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		< 0.001	The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.	Odds Ratio (OR)	28.73			2-Sided	95	12.248	67.387					Superiority
OG000 OG002

Secondary

Change From Baseline in MBL Volume to the Final Month

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.

All randomized and treated participants.

Posted

Least Squares Mean

Standard Error

Baseline and Final Month (the last 28 days prior to and including the Reference Day), up to Month 6

ID	Title	Description
OG000	Placebo	Placebo for both elagolix BID and E2/NETA QD
OG001	Elagolix	Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
OG002	Elagolix + E2/NETA	Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD

Secondary

Percentage of Participants With Suppression of Bleeding at the Final Month

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.

All randomized and treated participants with an assessment

Posted

Number

percentage of participants

Final Month (the last 28 days prior to and including the Reference Day), up to Month 6

ID	Title	Description
OG000	Placebo	Placebo for both elagolix BID and E2/NETA QD
OG001	Elagolix	Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
OG002	Elagolix + E2/NETA	Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD

Secondary

Change From Baseline in MBL Volume to Month 6

All randomized and treated participants with an assessment at given time point.

Posted

Least Squares Mean

Standard Error

Month 0 (Baseline), Month 6

ID	Title	Description
OG000	Placebo	Placebo for both elagolix BID and E2/NETA QD
OG001	Elagolix	Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
OG002	Elagolix + E2/NETA	Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD

Units	Counts

Secondary

Change From Baseline in MBL Volume to Month 3

All randomized and treated participants with an assessment at given time point.

Posted

Least Squares Mean

Standard Error

Month 0 (Baseline), Month 3

ID	Title	Description
OG000	Placebo	Placebo for both elagolix BID and E2/NETA QD
OG001	Elagolix	Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
OG002	Elagolix + E2/NETA	Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD

Units	Counts

Secondary

Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6

All randomized and treated participants with baseline hemoglobin <= 10.5 g/dL and an assessment at Month 6.

Posted

Number

percentage of participants

Month 0 (Baseline), Month 6

ID	Title	Description
OG000	Placebo	Placebo for both elagolix BID and E2/NETA QD
OG001	Elagolix	Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
OG002	Elagolix + E2/NETA	Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD

Units	Counts
Participants	OG000

Secondary

Change From Baseline in MBL Volume to Month 1

All randomized and treated participants with an assessment at given time point.

Posted

Least Squares Mean

Standard Error

Month 0 (Baseline), Month 1

ID	Title	Description
OG000	Placebo	Placebo for both elagolix BID and E2/NETA QD
OG001	Elagolix	Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
OG002	Elagolix + E2/NETA	Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo for both elagolix BID and E2/NETA QD	94	1	94	34	94
EG001	Elagolix	Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD	95	4	95	58	95
EG002	Elagolix + E2-NETA	Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD	189	7	189	80	189

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0010 events0 affected95 at risk EG0021 events1 affected189 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0010 events0 affected95 at risk EG0021 events1 affected189 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0011 events1 affected95 at risk EG0020 events0 affected189 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0011 events1 affected95 at risk EG0021 events1 affected189 at risk
APPENDICITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0011 events1 affected95 at risk EG0020 events0 affected189 at risk
CELLULITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0010 events0 affected95 at risk EG0021 events1 affected189 at risk
OBESITY	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0010 events0 affected95 at risk EG0021 events1 affected189 at risk
ABORTION COMPLETE	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected94 at risk EG0010 events0 affected95 at risk EG0020 events0 affected189 at risk
ANXIETY	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0010 events0 affected95 at risk EG0021 events1 affected189 at risk
DYSFUNCTIONAL UTERINE BLEEDING	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0010 events0 affected95 at risk EG0021 events1 affected189 at risk
DYSMENORRHOEA	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0010 events0 affected95 at risk EG0021 events1 affected189 at risk
MENORRHAGIA	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0010 events0 affected95 at risk EG0021 events1 affected189 at risk
PELVIC PAIN	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected94 at risk EG0011 events1 affected95 at risk EG0020 events0 affected189 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NAUSEA	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00011 events9 affected94 at risk EG0014 events4 affected95 at risk EG00215 events14 affected189 at risk
FATIGUE	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected94 at risk EG0013 events3 affected95 at risk EG00210 events10 affected189 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0009 events8 affected94 at risk EG0014 events4 affected95 at risk EG00211 events10 affected189 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected94 at risk EG0012 events2 affected95 at risk EG00212 events12 affected189 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected94 at risk EG0015 events5 affected95 at risk EG00210 events9 affected189 at risk
HEADACHE	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected94 at risk EG00114 events13 affected95 at risk EG00221 events20 affected189 at risk
LIBIDO DECREASED	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected94 at risk EG0013 events3 affected95 at risk EG00210 events10 affected189 at risk
MOOD SWINGS	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected94 at risk EG0016 events6 affected95 at risk EG0028 events6 affected189 at risk
DYSMENORRHOEA	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected94 at risk EG0010 events0 affected95 at risk EG0026 events6 affected189 at risk
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected94 at risk EG00124 events24 affected95 at risk EG00221 events20 affected189 at risk
HOT FLUSH	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected94 at risk EG00141 events41 affected95 at risk EG00237 events37 affected189 at risk

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D014592	Uterine Hemorrhage
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008599	Menstruation Disturbances

ID	Term
D007889	Leiomyoma
D008595	Menorrhagia

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D045166	Estradiol Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D009640	Norethindrone
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids

ID	Term
C539351	elagolix
D004958	Estradiol
D000077563	Norethindrone Acetate
C418365	estradiol, norethindrone drug combination