Conditions: Endometriosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 252
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. arm 2: Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. arm 3: Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12.

Interventions: intervention 1: Elagolix intervention 2: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) intervention 3: Placebo to Elagolix intervention 4: Placebo to DMPA-SC
Intervention descriptions: intervention 1: Provided as tablets for oral administration intervention 2: Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe. intervention 3: Matching placebo tablets for oral administration intervention 4: Matching placebo for subcutaneous injection in a pre-filled syringe

Protocol document: