Study of the Safety and Efficacy of Elagolix in Women Wit... | NCT03951077 | Trialant
NCT03951077
Sponsor
AbbVie
Status
Completed
Last Update Posted
Jun 8, 2022Actual
Enrollment
118Actual
Phase
Phase 2
Conditions
Polycystic Ovary Syndrome
Interventions
Elagolix
Placebo
Countries
United States
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT03951077
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M16-837
Secondary IDs
Not provided
Brief Title
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Official Title
Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
May 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 12, 2019Actual
Primary Completion Date
Feb 10, 2021Actual
Completion Date
Feb 10, 2021Actual
First Submitted Date
May 6, 2019
First Submission Date that Met QC Criteria
May 14, 2019
First Posted Date
May 15, 2019Actual
Results Waived
Not provided
Results First Submitted Date
May 16, 2022
Results First Submitted that Met QC Criteria
May 16, 2022
Results First Posted Date
Jun 8, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 27, 2021
Certification/Extension First Submitted that Passed QC Review
Dec 27, 2021
Certification/Extension First Posted Date
Dec 29, 2021Actual
Last Update Submitted Date
May 16, 2022
Last Update Posted Date
Jun 8, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).
Detailed Description
This is a phase 2, multicenter, double-blind (sponsor-unblinded), randomized, placebo-controlled study to assess the safety and efficacy of elagolix in women with PCOS. PCOS is one of the most common hormonal disorders in women of reproductive age, yet few treatment options are available. This study will help determine if elagolix can impact disordered hormonal dynamics in women with PCOS and at what dosage.
Conditions Module
Conditions
Polycystic Ovary Syndrome
Keywords
Polycystic Ovary Syndrome
Hormone
Elagolix
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
118Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Placebo taken orally twice a day (BID)
Drug: Placebo
Elagolix 25 mg BID
Experimental
Elagolix 25 mg taken orally BID plus placebo
Drug: Elagolix
Drug: Placebo
Elagolix 50 mg Once Daily (QD)
Experimental
Elagolix 50 mg taken orally QD plus placebo
Drug: Elagolix
Drug: Placebo
Elagolix 75 mg BID
Experimental
Elagolix 75 mg taken orally BID plus placebo
Drug: Elagolix
Drug: Placebo
Elagolix 150 mg QD
Experimental
Elagolix 150 mg taken orally QD plus placebo
Drug: Elagolix
Drug: Placebo
Elagolix 300 mg QD
Experimental
Elagolix 300 mg taken orally QD plus placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Elagolix
Drug
Capsule administered orally
Elagolix 150 mg QD
Elagolix 25 mg BID
Elagolix 300 mg QD
Elagolix 50 mg Once Daily (QD)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Menstrual Cycle Responders
A participant was considered a menstrual cycle responder if she has at least 2 normal menstrual cycles during the final 4 months of the treatment period. In addition, a participant was considered a complete menstrual cycle responder if she has normal menstrual cycles beginning at or before Month 3 that are maintained through Month 6 during the treatment period.
Week 0 (Baseline) to Week 24 (Month 6)
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1
Week 0 (Baseline), Week 1: before the morning dose (0 hour) and at 0.5 (± 5 minutes), 1 (± 5 minutes), 1.5 (± 5 minutes), 2 (± 15 minutes), 2.5 (± 15 minutes), 3 (± 15 minutes), 3.5 (± 15 minutes), and 4 (± 15 minutes) hours after dosing.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants with clinical diagnosis of PCOS.
Participants with a body mass index (BMI) of 18.5 to 38 kg/m^2 at time of Screening.
Exclusion Criteria:
Participants with newly diagnosed medical condition requiring intervention that has not been stabilized at least 30 days prior to Baseline.
Participants with a significant medical condition that require intervention during the course of study participation (such as anticipated major elective surgery).
Participants with an unstable medical condition (including, but not limited to, uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).
Snabes MC, Ng J, Li H, Ali I, Shebley M, Schlaff WD. Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome. F S Rep. 2023 Feb 21;4(2):206-212. doi: 10.1016/j.xfre.2023.02.007. eCollection 2023 Jun.
See Also Links
Label
URL
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
For details on when studies are available for sharing, please refer to the link below.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Participants were randomized 2:2:2:2:2:3 to the following treatments: 25 mg twice daily (BID), 50 mg once daily (QD), 75 mg BID, 150 mg QD, 300 mg QD, or placebo.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo taken orally BID
FG001
Elagolix 25 mg BID
Elagolix 25 mg taken orally BID plus placebo
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Randomized
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 2, 2020
May 16, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Drug: Elagolix
Drug: Placebo
Elagolix 75 mg BID
Orilissa
Placebo
Drug
Capsule administered orally
Elagolix 150 mg QD
Elagolix 25 mg BID
Elagolix 300 mg QD
Elagolix 50 mg Once Daily (QD)
Elagolix 75 mg BID
Placebo
Mobile
Alabama
36608
United States
Medical Ctr for Clin Research /ID# 205694
San Diego
California
92108
United States
UCSF Center for Reproductive Health /ID# 210836
San Francisco
California
94158-2518
United States
Avail Clinical Research /ID# 210873
DeLand
Florida
32720-0834
United States
University of FL Southside Women's Specialists /ID# 210872
Jacksonville
Florida
32207-4918
United States
Segal Institute for Clinical Research /ID# 205490
North Miami
Florida
33161-5821
United States
A Premier Medical Research of FL /ID# 215659
Orange City
Florida
32763-2833
United States
Virtus Research Consultant,LLC /ID# 205475
Wellington
Florida
33414
United States
Comprehensive Clinical Trials LLC /ID# 205458
West Palm Beach
Florida
33409
United States
Mount Vernon Clinical Res, LLC /ID# 205695
Atlanta
Georgia
30328
United States
Bingham Memorial Hospital /ID# 205606
Blackfoot
Idaho
83221
United States
Leavitt Womens Healthcare /ID# 205571
Idaho Falls
Idaho
83404-8322
United States
Womens Healthcare Assoc, DBA /ID# 211528
Idaho Falls
Idaho
83404
United States
Sonora Clinical Research /ID# 205623
Meridian
Idaho
83646-1144
United States
Asr, Llc /Id# 207037
Nampa
Idaho
83687
United States
PRN Professional Research Network of Kansas, LLC /ID# 205875
University of Puerto Rico, Medical Sciences Campus /ID# 212320
Rio Piedras
00935
Puerto Rico
Duplicate_Rodriguez-Ginorio, San Juan /ID# 211105
San Juan
00917
Puerto Rico
Mindful Medical Research /ID# 212323
San Juan
00918-3756
Puerto Rico
FG002
Elagolix 50 mg QD
Elagolix 50 mg taken orally QD plus placebo
FG003
Elagolix 75 mg BID
Elagolix 75 mg taken orally BID plus placebo
FG004
Elagolix 150 mg QD
Elagolix 150 mg taken orally QD plus placebo
FG005
Elagolix 300 mg QD
Elagolix 300 mg taken orally QD plus placebo
FG00027 subjects
FG00118 subjects
FG00218 subjects
FG00318 subjects
FG00419 subjects
FG00518 subjects
Randomized and Treated
FG00026 subjects
FG00118 subjects
FG00217 subjects
FG00317 subjects
FG00418 subjects
FG00518 subjects
COMPLETED
FG0009 subjects
FG0014 subjects
FG0025 subjects
FG0036 subjects
FG0043 subjects
FG0057 subjects
NOT COMPLETED
FG00018 subjects
FG00114 subjects
FG00213 subjects
FG00312 subjects
FG00416 subjects
FG00511 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0003 subjects
FG0013 subjects
FG0020 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG004
Non-Compliance With Study Procedures
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other, Not Specified
FG00012 subjects
FG00110 subjects
FG00210 subjects
FG0035 subjects
FG004
Did Not Receive Any Study Drug
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo taken orally BID
BG001
Elagolix 25 mg BID
Elagolix 25 mg taken orally BID plus placebo
BG002
Elagolix 50 mg QD
Elagolix 50 mg taken orally QD plus placebo
BG003
Elagolix 75 mg BID
Elagolix 75 mg taken orally BID plus placebo
BG004
Elagolix 150 mg QD
Elagolix 150 mg taken orally QD plus placebo
BG005
Elagolix 300 mg QD
Elagolix 300 mg taken orally QD plus placebo
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00026
BG00118
BG00217
BG00317
BG00418
BG00518
BG006114
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
BG00027.8± 4.60
BG00125.3± 5.19
BG00227.6± 4.85
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00026
BG00118
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG0015
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Body Mass Index (BMI)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
< 30 kg/m^2
BG0008
BG0015
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 Menstrual Cycle Responders
A participant was considered a menstrual cycle responder if she has at least 2 normal menstrual cycles during the final 4 months of the treatment period. In addition, a participant was considered a complete menstrual cycle responder if she has normal menstrual cycles beginning at or before Month 3 that are maintained through Month 6 during the treatment period.
Full Analysis Set: all randomly assigned participants who have received at least one dose of study drug in this study. Based on observed cases only.
Posted
Number
90% Confidence Interval
percentage of participants
Week 0 (Baseline) to Week 24 (Month 6)
ID
Title
Description
OG000
Placebo
Placebo taken orally BID
OG001
Elagolix 25 mg BID
Elagolix 25 mg taken orally BID plus placebo
OG002
Elagolix 50 mg QD
Elagolix 50 mg taken orally QD plus placebo
OG003
Elagolix 75 mg BID
Elagolix 75 mg taken orally BID plus placebo
OG004
Elagolix 150 mg QD
Elagolix 150 mg taken orally QD plus placebo
OG005
Elagolix 300 mg QD
Elagolix 300 mg taken orally QD plus placebo
Units
Counts
Participants
OG00026
OG00118
OG00217
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.7(0.00 to 16.29)
OG0010(0.00 to 0.00)
OG0020(0.00 to 0.00)
OG003
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
Across the strata, 90% confidence interval (CI) for adjusted difference and p-value were calculated according to the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (Baseline FG score [< 8, ≥ 8], and baseline normal/obese status [BMI < 30, ≥ 30]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.
Cochran-Mantel-Haenszel
0.300
Adjusted Response Rate Difference
-5.9
2-Sided
90
-15.38
3.49
Superiority
Secondary
Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1
Full Analysis Set: all randomly assigned participants who have received at least one dose of study drug in this study. Participants with an assessment.
Posted
Least Squares Mean
Standard Error
(IU/L)*hr
Week 0 (Baseline), Week 1: before the morning dose (0 hour) and at 0.5 (± 5 minutes), 1 (± 5 minutes), 1.5 (± 5 minutes), 2 (± 15 minutes), 2.5 (± 15 minutes), 3 (± 15 minutes), 3.5 (± 15 minutes), and 4 (± 15 minutes) hours after dosing.
ID
Title
Description
OG000
Placebo
Placebo taken orally BID
OG001
Elagolix 25 mg BID
Elagolix 25 mg taken orally BID plus placebo
OG002
Elagolix 50 mg QD
Elagolix 50 mg taken orally QD plus placebo
OG003
Elagolix 75 mg BID
Elagolix 75 mg taken orally BID plus placebo
OG004
Elagolix 150 mg QD
Time Frame
From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Placebo taken orally BID
0
26
0
26
10
26
EG001
Elagolix 25 mg BID
Elagolix 25 mg taken orally BID plus placebo
0
18
1
18
9
18
EG002
Elagolix 50 mg QD
Elagolix 50 mg taken orally QD plus placebo
0
17
0
17
8
17
EG003
Elagolix 75 mg BID
Elagolix 75 mg taken orally BID plus placebo
0
17
0
17
6
17
EG004
Elagolix 150 mg QD
Elagolix 150 mg taken orally QD plus placebo
0
18
0
18
11
18
EG005
Elagolix 300 mg QD
Elagolix 300 mg taken orally QD plus placebo
0
18
0
18
10
18
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
CHOLECYSTITIS CHRONIC
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected17 at risk
EG0030 events0 affected17 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected18 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected17 at risk
EG0030 events0 affected17 at risk
EG0042 events2 affected18 at risk
EG0050 events0 affected18 at risk
HYPERANDROGENISM
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
VISUAL IMPAIRMENT
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected17 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
FOOD POISONING
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected17 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 events3 affected26 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected17 at risk
EG003
SALIVARY GLAND CYST
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
FATIGUE
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
PYREXIA
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected17 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected17 at risk
EG003
CHRONIC TONSILLITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected17 at risk
EG003
FOLLICULITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
ORAL BACTERIAL INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
PILONIDAL CYST
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
SCHISTOSOMIASIS CUTANEOUS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected17 at risk
EG003
VULVOVAGINAL CANDIDIASIS
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected17 at risk
EG003
NAIL AVULSION
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD GLUCOSE INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD INSULIN INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected17 at risk
EG003
BLOOD TRIGLYCERIDES INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
BONE DENSITY DECREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
LIPIDS INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
LIVER FUNCTION TEST INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected17 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
DYSLIPIDAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected17 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected17 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
VITAMIN D DEFICIENCY
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected17 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected17 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected17 at risk
EG003
ATTENTION DEFICIT HYPERACTIVITY DISORDER
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected17 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected17 at risk
EG003
MOOD SWINGS
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
STRESS
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
AMENORRHOEA
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
CERVICAL DYSPLASIA
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected17 at risk
EG003
DYSFUNCTIONAL UTERINE BLEEDING
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
MENORRHAGIA
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
PELVIC DISCOMFORT
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected17 at risk
EG003
PREMENSTRUAL SYNDROME
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
ADENOIDAL HYPERTROPHY
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
TONSILLAR HYPERTROPHY
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0022 events1 affected17 at risk
EG003
SKIN IRRITATION
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected17 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0002 events2 affected26 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected17 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
D006058
Gonadal Disorders
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C539351
elagolix
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
3 subjects
FG0052 subjects
2 subjects
FG0053 subjects
1 subjects
FG0050 subjects
9 subjects
FG0056 subjects
1 subjects
FG0050 subjects
26.9
± 3.27
BG00425.1± 4.19
BG00526.1± 4.35
BG00626.5± 4.50
17
BG00317
BG00418
BG00518
BG006114
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
6
BG0033
BG0044
BG0054
BG00627
Not Hispanic or Latino
BG00021
BG00113
BG00211
BG00314
BG00414
BG00514
BG00687
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
0
BG0030
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0061
Black or African American
BG0006
BG0014
BG0021
BG0035
BG0047
BG0054
BG00627
White
BG00019
BG00113
BG00216
BG00312
BG00411
BG00514
BG00685
More than one race
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
5
BG0035
BG0045
BG0055
BG00633
≥ 30 kg/m^2
BG00018
BG00113
BG00212
BG00312
BG00413
BG00513
BG00681
17
OG00418
OG00518
0
(0.00 to 0.00)
OG0040(0.00 to 0.00)
OG0055.6(0.00 to 14.44)
OG000
OG002
Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score [< 8, ≥ 8], and baseline normal/obese status [BMI < 30, ≥ 30]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.
Cochran-Mantel-Haenszel
0.320
Adjusted Response Rate Difference
-5.9
2-Sided
90
-15.65
3.86
Superiority
OG000
OG003
Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score [< 8, ≥ 8], and baseline normal/obese status [BMI < 30, ≥ 30]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.
Cochran-Mantel-Haenszel
0.315
Adjusted Response Rate Difference
-5.6
2-Sided
90
-14.87
3.59
Superiority
OG000
OG004
Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score [< 8, ≥ 8], and baseline normal/obese status [BMI < 30, ≥ 30]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.
Cochran-Mantel-Haenszel
0.265
Adjusted Response Rate Difference
-6.7
2-Sided
90
-16.63
3.19
Superiority
OG000
OG005
Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score [< 8, ≥ 8], and baseline normal/obese status [BMI < 30, ≥ 30]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.
Cochran-Mantel-Haenszel
0.914
Adjusted Response Rate Difference
-0.8
2-Sided
90
-13.10
11.48
Superiority
Elagolix 150 mg taken orally QD plus placebo
OG005
Elagolix 300 mg QD
Elagolix 300 mg taken orally QD plus placebo
Units
Counts
Participants
OG00024
OG00115
OG00215
OG00316
OG00413
OG00515
Title
Denominators
Categories
Title
Measurements
OG000-1.82± 2.292
OG001-7.75± 2.867
OG002-10.65± 2.861
OG003-17.92± 2.692
OG004-7.97± 3.112
OG005-13.54± 2.763
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
P-value is from mixed-effect model repeated measure (MMRM) with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (< 8, ≥ 8), and baseline normal/obese status (BMI < 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.
MMRM
0.087
Least Squares (LS) Mean of Difference
-5.93
Standard Error of the Mean
3.429
2-Sided
90
-11.628
-0.231
Superiority
OG000
OG002
P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (< 8, ≥ 8), and baseline normal/obese status (BMI < 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.
MMRM
0.012
LS Mean of Difference
-8.83
Standard Error of the Mean
3.435
2-Sided
90
-14.533
-3.118
Superiority
OG000
OG003
P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (< 8, ≥ 8), and baseline normal/obese status (BMI < 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.
MMRM
<0.001
LS Mean of Difference
-16.10
Standard Error of the Mean
3.356
2-Sided
90
-21.673
-10.519
Superiority
OG000
OG004
P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (< 8, ≥ 8), and baseline normal/obese status (BMI < 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.
MMRM
0.091
LS Mean of Difference
-6.15
Standard Error of the Mean
3.593
2-Sided
90
-12.116
-0.176
Superiority
OG000
OG005
P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (< 8, ≥ 8), and baseline normal/obese status (BMI < 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.