Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of Endometriosis

Sponsor
AbbVie
Study ID
NCT00437658
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Elagolix — DRUG
    Provided as tablets for oral administration
  • Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) — DRUG
    Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe.
  • Placebo to Elagolix — DRUG
    Matching placebo tablets for oral administration
  • Placebo to DMPA-SC — DRUG
    Matching placebo for subcutaneous injection in a pre-filled syringe

Study Details

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.

Key Dates

Start date
Dec 11, 2006
Status verified
Mar 2018
Primary completion
Nov 24, 2008
Completion
Nov 24, 2008

Study Design

Enrollment
252 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elagolix 75 mg BID
    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.
  • Experimental: Elagolix 150 mg QD
    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.
  • Active Comparator: DMPA-SC
    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.

Primary Outcome Measure

Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24 [ Time Frame: Baseline and week 24 ]

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