M14702

M14702

Primary Investigator: Karram

Drug/Device Information
To evaluate the safety and efficacy of elagolix in combination with two doses of concomitant hormonal add-back therapy (E2/NETA) in endometriosis-associated pain (EAP) in premenopausal women
Elagolix is an orally active, non-peptide GnRH antagonist
The first 6 months of the treatment period employ a randomized, double-blind, placebo-controlled design
Randomized in a 1:1:2:2 ratio as follows: placebo, elagolix 200 mg BID, elagolix 200 mg BID plus 0.5 mg E2/0.1 mg NETA QD or elagolix 200 mg BID plus 1.0 mg E2/0.5 mg NETA QD
The last 6 months of the treatment period is also a randomized, double-blind design, but does not include a placebo arm
Subjects previously on active treatment during the first 6 months of treatment will continue with the same dosing regimen
Subjects previously on placebo will be randomized 1:1:1 as follows: elagolix 200 mg BID, elagolix 200 mg BID plus 0.5 mg E2/0.1 mg NETA QD or elagolix 200 mg BID plus 1.0 mg E2/0.5 mg NETA QD