At a glance
ClinicalIndex Comparison Record- ✓Female, aged 18 to 49 years inclusive
- ✓Endometriosis diagnosed by laparoscopic visualization within 8 years of screening start with recurrent or persistent symptoms
- ✓Total CPSSS score ≥6 at screening and baseline, with at least 2 points each in dysmenorrhea and nonmenstrual pelvic pain categories
- ✓Menstrual cycles of 28 days ±5 days
- ✕Currently receiving or received GnRH agonist, GnRH antagonist, or danazol within 6 months of screening start
- ✕Currently receiving or received DMPA-SC or DMPA-IM within 3 months of screening start
- ✕Nonresponsive to prior GnRH agonist or antagonist therapy for endometriosis management
- ✕Currently using or received hormonal contraception or other hormonal therapy within 1 month of screening start
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Double-blind, Active-controlled Study to Assess the Safety and Efficacy of NBI-56418 in Subjects With Endometriosis
In Brief
A Phase 2 clinical trial evaluating Elagolix, Subcutaneous depot medroxyprogesterone acetate (DMPA-SC), and 2 other interventions for Endometriosis. Completed, enrolled 252 participants.
Detailed Summary
This study is designed to assess the effects of elagolix versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC; also known as depo-provera) on bone mineral density (BMD) during treatment for 24 weeks with a subsequent 24-week post-treatment period.
Study Details
Timeline
Interventions
Provided as tablets for oral administration
Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe.
Matching placebo tablets for oral administration
Matching placebo for subcutaneous injection in a pre-filled syringe