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Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

NCT02654054•AbbVie

View on ClinicalTrials.gov

Summary

This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Eligibility

Age

18 - 51 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Subject is a premenopausal female at the time of Screening.
•Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).
•Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss \> 80 mL during each of two screening menses as measured by the alkaline hematin method.
•Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.
•Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.

Exclusion Criteria

•Subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder.
•Subject has history of osteoporosis or other metabolic bone disease.
•Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
•Subject has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
•Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.

Locations (96)

Summers, Birmingham, AL /ID# 139684

Birmingham, Alabama, United States

University of South Alabama /ID# 148763

Mobile, Alabama, United States

WCCT Global, LLC /ID# 145666

Costa Mesa, California, United States

American Clinical Trials /ID# 147374

Hawaiian Gardens, California, United States

Grossmont Ctr Clin Research /ID# 144011

La Mesa, California, United States

Long Beach Clinical Trial Serv /ID# 152424

Long Beach, California, United States

National Research Institute /ID# 151629

Los Angeles, California, United States

University of California, Los Angeles /ID# 144107

Los Angeles, California, United States

Beach OBGYN Medical Group /ID# 151414

Newport Beach, California, United States

Advanced RX Clinical Research /ID# 149168

Westminster, California, United States

Key Dates

Start Date

December 22, 2015

Primary Completion Date

January 18, 2018

Completion Date

December 12, 2018

Last Updated

June 29, 2020

Enrollment

413

ACTUAL participants

Conditions

Uterine FibroidsHeavy Menstrual Bleeding

Interventions

Elagolix

DRUG

Placebo for Estradiol/Norethindrone Acetate

DRUG

Estradiol/Norethindrone Acetate

DRUG

Placebo for Elagolix

DRUG

Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)

NCT06634719

Heavy Menstrual Bleeding

View study

ACTIVE_NOT_RECRUITING

Laparoscopic Myomectomy Based on a Fully Enclosed Protective Device: A Novel Surgical Technique Achieving Tumor-Free Protection Throughout the Entire Procedure

NCT07474688

Uterine Fibroids (Leiomyoma)

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NOT_YET_RECRUITING

Evaluating the Reliability and Validity of the Arabic Version of the SAMANTA Questionnaire: A Step Toward Improved Diagnosis of Heavy Menstrual Bleeding

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Inclusion Criteria

Exclusion Criteria

Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)

Laparoscopic Myomectomy Based on a Fully Enclosed Protective Device: A Novel Surgical Technique Achieving Tumor-Free Protection Throughout the Entire Procedure

Evaluating the Reliability and Validity of the Arabic Version of the SAMANTA Questionnaire: A Step Toward Improved Diagnosis of Heavy Menstrual Bleeding

Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial

POPQ Associated With Total Laparoscopic Hysterectomy

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