Efficacy and Safety Study of Elagolix in Women With Endometriosis

Conditions

• Endometriosis, Pain

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 49 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Matching placebo tablets taken orally once a day
• Elagolix — DRUG
  Immediate release (IR) tablets taken orally once a day

Study Details

The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its effects on endometriosis related pelvic pain and its safety.

Key Dates

Start date

Oct 12, 2009

Status verified

Apr 2018

Primary completion

Sep 22, 2010

Completion

Sep 22, 2010

Study Design

Enrollment

137 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elagolix 150 mg
  Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period.
• Placebo Comparator: Placebo
  Participants received placebo orally once a day for 8 weeks during the double-blind treatment period and switched to receive 150 mg elagolix for 16 weeks during the open-label treatment period.

Primary Outcome Measure

Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Double-blind Treatment Phase [ Time Frame: Baseline and Weeks 4 and 8 ]