CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 82 enrolled
Drug / intervention
Elagolix +1 moredrug
Likely dose
Elagolix oral tablet (specific dose not stated in provided text)AI-extracted
Key inclusion· 4
  • ✓Documented uterine fibroids on pelvic ultrasound (transabdominal and/or transvaginal)
  • ✓Heavy menstrual bleeding (>80 mL) associated with uterine fibroids measured during screening
  • ✓Negative urine and/or serum pregnancy test at washout (if applicable), screening, and prior to first dose
  • ✓Adequate endometrial biopsy during screening showing no clinically significant endometrial pathology
Key exclusion· 5
  • ✕Clinically significant gynecological disorder on screening pelvic ultrasound, SIS, or MRI
  • ✕History of osteoporosis, osteopenia, or other metabolic bone disease
  • ✕Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis
  • ✕History of major depression or PTSD within 2 years of screening, or other major psychiatric disorder (schizophrenia, bipolar disorder) at any time

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03886220
NCT03886220Phase 4Completed
CompareCT.gov

A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

AbbVie·interventional·Posted Mar 22, 2019·Updated Mar 31, 2022

In Brief

A Phase 4 clinical trial evaluating Elagolix and Placebo for Uterine Fibroids. Completed, enrolled 82 participants across 48 sites in 2 countries.

Detailed Summary

The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Fibroids
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedMar 22, 2019
Enrollment StartApr 12, 2019
Primary CompletionMar 31, 2021
Study CompletionApr 28, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.3 years ago

Interventions

Elagolixdrug

Oral; Tablet

Placebodrug

Oral; Tablet