NCT01817530

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
571

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

April 8, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

July 21, 2020

Completed
Last Updated

July 21, 2020

Status Verified

June 1, 2020

Enrollment Period

2.1 years

First QC Date

March 21, 2013

Results QC Date

June 9, 2020

Last Update Submit

July 7, 2020

Conditions

Heavy Uterine BleedingUterine Fibroids

Keywords

Uterine FibroidsLeiomyomataElagolixMenorrhagiaElagolix sodiumHeavy Uterine BleedingABT-620

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Final Month (last 28 days of treatment)

Secondary Outcomes (18)

  • 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)

  • 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)

  • 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 With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month

    Baseline, Final Month (last 28 days of treatment)

  • 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)

  • +13 more secondary outcomes

Study Arms (8)

Cohort 1: Placebo

PLACEBO COMPARATOR

Placebo for elagolix and placebo for E2/NETA twice daily (BID)

Other: Elagolix placeboDrug: E2/NETA placebo

Cohort 1: Elagolix 300 mg BID

EXPERIMENTAL

Elagolix 300 mg BID alone

Drug: ElagolixDrug: E2/NETA placebo

Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD

EXPERIMENTAL

Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD)

Drug: ElagolixDrug: 0.5 mg estradiol / 0.1 mg norethindrone acetate

Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD

EXPERIMENTAL

Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD

Drug: ElagolixDrug: 1 mg estradiol / 0.5 mg norethindrone acetate

Cohort 2: Placebo

PLACEBO COMPARATOR

Placebo for elagolix and E2/NETA QD

Other: Elagolix placeboDrug: E2/NETA placebo

Cohort 2: Elagolix 600 mg QD

EXPERIMENTAL

Elagolix 600 mg QD alone

Drug: ElagolixDrug: E2/NETA placebo

Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD

EXPERIMENTAL

Elagolix 600 mg QD plus LD E2/NETA QD

Drug: ElagolixDrug: 0.5 mg estradiol / 0.1 mg norethindrone acetate

Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD

EXPERIMENTAL

Elagolix 600 mg QD plus SD E2/NETA QD

Drug: ElagolixDrug: 1 mg estradiol / 0.5 mg norethindrone acetate

Interventions

Elagolix placeboOTHER

oral coated tablet

Cohort 1: PlaceboCohort 2: Placebo
ElagolixDRUG

oral coated tablet

Also known as: ABT-620
Cohort 1: Elagolix 300 mg BIDCohort 1: Elagolix 300 mg BID plus LD E2/NETA QDCohort 1: Elagolix 300 mg BID plus SD E2/NETA QDCohort 2: Elagolix 600 mg QDCohort 2: Elagolix 600 mg QD plus LD E2/NETA QDCohort 2: Elagolix 600 mg QD plus SD E2/NETA QD
0.5 mg estradiol / 0.1 mg norethindrone acetateDRUG

oral hard capsule

Also known as: Activelle, Activella, low dose (LD) E2/NETA
Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QDCohort 2: Elagolix 600 mg QD plus LD E2/NETA QD
1 mg estradiol / 0.5 mg norethindrone acetateDRUG

oral hard capsule

Also known as: Activelle, Activella, standard dose (SD) E2/NETA
Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QDCohort 2: Elagolix 600 mg QD plus SD E2/NETA QD
E2/NETA placeboDRUG

oral hard capsule

Cohort 1: Elagolix 300 mg BIDCohort 1: PlaceboCohort 2: Elagolix 600 mg QDCohort 2: Placebo

Eligibility Criteria

Age18 Years - 51 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Carr BR, Stewart EA, Archer DF, Al-Hendy A, Bradley L, Watts NB, Diamond MP, Gao J, Owens CD, Chwalisz K, Duan WR, Soliman AM, Dufek MB, Simon JA. Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1252-1264. doi: 10.1097/AOG.0000000000002933.

    PMID: 30303923DERIVED

MeSH Terms

Conditions

LeiomyomaMenorrhagia

Interventions

elagolixEstradiolNorethindrone Acetateestradiol, norethindrone drug combination

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNorethindroneNorpregnenesNorpregnanesNorsteroids

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
abbvieclinicaltrials@abbvie.com
800-633-9110

Study Officials

  • Charlotte Owens, MD

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 25, 2013

Study Start

April 8, 2013

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

July 21, 2020

Results First Posted

July 21, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
More information