A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Estradiol/Norethindrone Acetate in Subjects with Moderate to Severe Endometriosis-Associated Pain

Purpose

1) assess the safety and efficacy of elagolix 200 mg administered twice daily (BID) in combination with low dose Estradiol/Norethindrone acetate (E2/NETA) QD and elagolix 200 mg BID in combination with standard dose Estradiol/Norethindrone acetate (E2/NETA) QD compared to placebo at 6 months

2) to assess the effect of elagolix 200 mg BID in combination with low dose E2/NETA QD and elagolix 200 mg BID in combination with standard dose E2/NETA QD on bone mineral density (BMD) compared to placebo at 6 months and compared to elagolix 200 mg BID alone at 12 months in premenopausal women with moderate to severe endometriosis-associated pain.

Criteria

Premenopausal female 18 to 49 years of age

Documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization or histology within 10 years      

Subject must have two documented menstrual cycles with a cycle length of 21 – 38 days

Can not:

Be pregnant or breastfeeding, or is planning a pregnancy during the duration of study participation

Be less than 6 months postpartum or 3 months post-abortion

Have had any major surgery (including laparotomy for endometriosis) within 3 months OR endometrial ablation within 6 months OR minor surgery (including laparoscopy for endometriosis) within 1 month prior to the Screening visit.

No chronic pelvic pain that is not caused by endometriosis (e.g., interstitial cystitis, adenomyosis [as a dominant condition diagnosed by MRI or ultrasound], fibroids, pelvic inflammatory disease [PID], non-endometriosis-related pelvic adhesive disease, irritable bowel syndrome), that requires chronic analgesic

No other chronic pain syndrome

Details

Stipend:  $25.00 - $150.00 depending on visit; $25.00 per most procedures

The total duration for a subject's participation in this study is approximately 27 to 50 months consisting of 4 study periods:

Washout Period – up to 10 months prior to Screening (only applicable if subject is taking exclusionary medication at the time of consent; duration of washout depends on the type of exclusionary medication being taken)

Screening Period – approximately 1.5 to 4 months prior to first dose of study drug

Treatment Period – up to 24-month treatment duration

Follow-Up Period – up to12 month duration following the last dose of study drug. Subjects are expected to enter Follow-Up after Treatment Month 24, or if a subject prematurely discontinues from the Treatment Period at the time of or after Treatment Month 6.    

Interested in more information? Contact Us:

Greg Phillips, M.D., Principal Investigator

IRB: CGIRB
IRB Number:
Trial Type: Drug
Sponsor: Abbvie