Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-28

Study Completion Date

2016-04-15

Brief Summary

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A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in pre-menopausal women.

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Detailed Description

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This is a Phase 3 multicenter, double blind randomized study to assess the continued safety and efficacy of the 150 mg once daily (QD) and 200 mg twice daily (BID) doses of elagolix in premenopausal women with moderate to severe endometriosis-associated pain who completed the 6 month treatment period in the pivotal study M12-665 (NCT01620528). The study consists of 2 periods: a 6 month Treatment Period and a post treatment follow-up period of up to 12 months.

Participants who received elagolix in the pivotal study who met all entry criteria continued to receive the same dose, either elagolix 150 mg QD or elagolix 200 mg BID for up to an additional 6 months in this extension study; participants who received placebo in the pivotal study were randomized in a 1:1 ratio to receive either elagolix 150 mg QD or elagolix 200 mg BID for up to 6 months.

An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis associated pain on a daily basis.

All participants who prematurely discontinued treatment (unless pregnant or elected surgery for endometriosis) or completed the 6-month Treatment Period in this extension study were to enter the Post-treatment Follow-up (PTFU) Period within this study for up to 12 months.

Conditions

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Endometriosis

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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Elagolix 150 mg QD

Participants received elagolix 150 mg tablets once a day (QD) for 6 months.

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

Elagolix tablets administered orally

Elagolix 200 mg BID

Participants received elagolix 200 mg tablets twice a day (BID) for 6 months.

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

Elagolix tablets administered orally

Interventions

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Elagolix

Elagolix tablets administered orally

Intervention Type DRUG

Other Intervention Names

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Orilissa™

Eligibility Criteria

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Inclusion Criteria

* Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528)
* Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period

Exclusion Criteria

* Clinically significant gynecological condition
* Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip
* Plans to become pregnant in the next 18 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No