Table 3.

Clinical Trial of Elagolix with Add-Back Therapy

Phase 3, randomized, double-blind placebo-controlled study

Enrollment: 680 adult women with moderate-to-severe endometriosis-associated pain

Treatment arms:

Elagolix 200 mg BID + low-dose estradiol/norethindrone acetate

Elagolix 200 mg BID

Placebo

Duration: 12 months

Primary outcome measures:

Proportion of responders based on dysmenorrhea at month 6

Proportion of responders based on NMPP at month 6

Secondary outcome measures:

Change from baseline in dysmenorrhea (months 3, 6, and 12)

Change from baseline in dyspareunia (months 3, 6, and 12)

Change from baseline in numeric rating scale (months 3, 6, and 12)

Change from baseline in NMPP (months 3, 6, and 12)

ClinicalTrials.gov identifier: NCT03213457.

BID, twice daily; NMPP, nonmenstrual pelvic pain.