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Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF) | Clinical Trials | Clareo Health

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Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

NCT01817530•AbbVie

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 51 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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

Key Dates

Start Date

April 8, 2013

Primary Completion Date

June 1, 2015

Completion Date

December 1, 2015

Last Updated

July 21, 2020

Enrollment

571

ACTUAL participants

Conditions

Heavy Uterine BleedingUterine Fibroids

Interventions

Elagolix placebo

OTHER

Elagolix

DRUG

0.5 mg estradiol / 0.1 mg norethindrone acetate

DRUG

1 mg estradiol / 0.5 mg norethindrone acetate

DRUG

E2/NETA placebo

DRUG

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)

View study

NOT_YET_RECRUITING

POPQ Associated With Total Laparoscopic Hysterectomy

NCT07137299

Uterine Fibroids (UF)Abnormal Uterine Bleeding Unrelated to Menstrual Cycle+2 more

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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: July 21, 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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Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

Inclusion Criteria

Exclusion Criteria

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

POPQ Associated With Total Laparoscopic Hysterectomy

A Trial of SHR7280 in Healthy Subjects

Point of Care 3D Ultrasound for Various Applications: A Pilot Study

Laparoscopic Cryoablation of Uterine Fibroids

Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids