Completed
A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
What is being tested
Elagolix placebo
+ E2/NETA placebo
+ Elagolix
OtherDrug
Who is being recruted
Urogenital Diseases+14
+ Genital Diseases
+ Female Urogenital Diseases and Pregnancy Complications
From 18 to 51 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: April 2013
Summary
Principal SponsorAbbVie
Last updated: July 21, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: April 8, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorAbbVie
Last updated: July 21, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
571 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.From 18 to 51 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleHemorrhageMenstruation DisturbancesNeoplasmsNeoplasms by Histologic TypeNeoplasms, Muscle TissuePathologic ProcessesPathological Conditions, Signs and SymptomsUterine DiseasesUterine HemorrhageNeoplasms, Connective and Soft TissueFemale Urogenital DiseasesLeiomyomaMenorrhagia
Criteria
3 inclusion criteria required to participate
Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound
Subject has heavy uterine bleeding associated with uterine fibroids
Subject is pre-menopausal female 18 to 51 years of age at Screening
4 exclusion criteria prevent from participating
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
Subject has a history of osteoporosis or other metabolic bone disease
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 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
8 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboPlacebo for elagolix and placebo for E2/NETA twice daily (BID)
Group II
ExperimentalElagolix 300 mg BID alone
Group III
ExperimentalElagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD)
Group IV
ExperimentalElagolix 300 mg BID plus standard-dose (SD) E2/NETA QD
Group 5
PlaceboPlacebo for elagolix and E2/NETA QD
Group 6
ExperimentalElagolix 600 mg QD alone
Group 7
ExperimentalElagolix 600 mg QD plus LD E2/NETA QD
Group 8
ExperimentalElagolix 600 mg QD plus SD E2/NETA QD
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers