An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis

Conditions

• Endometriosis, Pain

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 49 Years

Healthy Volunteers

Not accepted

Interventions

• Elagolix — DRUG
  Elagolix tablets administered orally
• placebo — DRUG
  Placebo tablet administered orally

Study Details

This study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density.

Key Dates

Start date

Feb 19, 2008

Status verified

Mar 2018

Primary completion

Apr 20, 2009

Completion

Aug 28, 2009

Study Design

Enrollment

155 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.
• Experimental: Elagolix 150 mg
  Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.
• Experimental: Elagolix 250 mg
  Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.

Primary Outcome Measure

Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12 [ Time Frame: Baseline and week 12 ]