Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain
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About
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis associated pain in adult pre-menopausal women who completed 6 months treatment in pivotal Study M12-671 (NCT01931670).
Full description
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 once daily (QD) or elagolix 200 mg twice daily (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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Subject has completed the 6-Month Treatment Period in pivotal study M12-671.
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
496 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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