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

NCT ID: NCT01817530

Last Updated: 2020-07-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

571 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-08

Study Completion Date

2015-12-31

Brief Summary

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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.

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Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

NCT03751124

Uterine Leiomyoma Uterine Fibroids
COMPLETED PHASE3

Detailed Description

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Conditions

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Heavy Uterine Bleeding Uterine Fibroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1: Placebo

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

Group Type PLACEBO_COMPARATOR

Elagolix placebo

Intervention Type OTHER

oral coated tablet

E2/NETA placebo

Intervention Type DRUG

oral hard capsule

Cohort 1: Elagolix 300 mg BID

Elagolix 300 mg BID alone

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

oral coated tablet

E2/NETA placebo

Intervention Type DRUG

oral hard capsule

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

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

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

oral coated tablet

0.5 mg estradiol / 0.1 mg norethindrone acetate

Intervention Type DRUG

oral hard capsule

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

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

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

oral coated tablet

1 mg estradiol / 0.5 mg norethindrone acetate

Intervention Type DRUG

oral hard capsule

Cohort 2: Placebo

Placebo for elagolix and E2/NETA QD

Group Type PLACEBO_COMPARATOR

Elagolix placebo

Intervention Type OTHER

oral coated tablet

E2/NETA placebo

Intervention Type DRUG

oral hard capsule

Cohort 2: Elagolix 600 mg QD

Elagolix 600 mg QD alone

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

oral coated tablet

E2/NETA placebo

Intervention Type DRUG

oral hard capsule

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

Elagolix 600 mg QD plus LD E2/NETA QD

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

oral coated tablet

0.5 mg estradiol / 0.1 mg norethindrone acetate

Intervention Type DRUG

oral hard capsule

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

Elagolix 600 mg QD plus SD E2/NETA QD

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

oral coated tablet

1 mg estradiol / 0.5 mg norethindrone acetate

Intervention Type DRUG

oral hard capsule

Interventions

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Elagolix placebo

oral coated tablet

Intervention Type OTHER

Elagolix

oral coated tablet

Intervention Type DRUG

0.5 mg estradiol / 0.1 mg norethindrone acetate

oral hard capsule

Intervention Type DRUG

1 mg estradiol / 0.5 mg norethindrone acetate

oral hard capsule

Intervention Type DRUG

E2/NETA placebo

oral hard capsule

Intervention Type DRUG

Other Intervention Names

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ABT-620 Activelle, Activella, low dose (LD) E2/NETA Activelle Activella standard dose (SD) E2/NETA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlotte Owens, MD

Role: STUDY_DIRECTOR

AbbVie

References

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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.

Reference Type DERIVED
PMID: 30303923 (View on PubMed)

Other Identifiers

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2013-000082-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M12-813

Identifier Type: -

Identifier Source: org_study_id

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