Clinical trial NCT00619866: An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis, Pain
Keywords: bone mineral density
Pelvic Pain
estradiol
NBI-56418
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a Phase II, multicenter, randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of elagolix at two dose levels administered once daily for up to 6 months. Participants will be randomized (1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (QD); 250 mg elagolix QD or placebo QD. Following 12 weeks of dosing, participants will continue in the study for an additional 12 weeks; participants randomized to elagolix will continue to receive their assigned dose and participants randomized to placebo will be re-randomized to receive one of the two doses of elagolix for 12 weeks in a double-blind fashion. Six weeks after the last dose of study drug at the end of Week 24, a follow-up visit will be performed (end of Week 30).

Eligibility criteria: Inclusion Criteria:

* Be female, aged 18 to 49 years, inclusive
* Have moderate to severe pelvic pain due to endometriosis
* Have been surgically (laparoscopy) diagnosed with endometriosis within the last 8 years and have recurrent or persistent endometriosis symptoms
* Have regular menstrual cycle
* Have a body mass index (BMI) of 18 to 36 kg/m², inclusive
* Agree to use two forms of non-hormonal contraception during the study

Exclusion Criteria:

* Are currently receiving gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or have received any of these agents within 6 months of the start of screening
* Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening
* Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month
* Have had surgery for endometriosis within the last month
* Have had a hysterectomy or bilateral oophorectomy
* Are using systemic steroids on a chronic or regular basis within 3 months
* Have uterine fibroids ≥ 3 cm in diameter
* Have pelvic pain that is not caused by endometriosis
* Have unstable medical condition or chronic disease
* Have been pregnant within the last six months
* Currently breast feeding

Primary outcomes:
measure: Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain
timeFrame: Baseline and weeks 4 and 8
measure: Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score
timeFrame: Baseline and weeks 4, 8, and 12
measure: Change From Baseline in the Monthly Mean Dysmenorrhea Score
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Percentage of Days With No Pain Based on NRS
timeFrame: Baseline and weeks 4, 8 and 12
measure: Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment
timeFrame: Baseline and weeks 4, 8 and 12
measure: Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment
timeFrame: Baseline and weeks 4, 8 and 12
measure: Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment
timeFrame: Baseline and weeks 4, 8 and 12
measure: Change From Baseline in the Percentage of Days of Any Analgesic Use
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in the Percentage of Days of Prescription Analgesic Use
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in the Percentage of Days of Narcotic Analgesic Use
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Percentage of Participants With 30% Decrease From Baseline in Monthly Mean NRS
timeFrame: Baseline and weeks 4, 8 and 12
measure: Percentage of Participants With 30% Decrease From Baseline in Monthly Peak NRS
timeFrame: Baseline and weeks 4, 8 and 12
measure: Percentage of Participants With 50% Decrease From Baseline in Monthly Mean NRS
timeFrame: Baseline and weeks 4, 8 and 12
measure: Percentage of Participants With 50% Decrease From Baseline in Monthly Peak NRS
timeFrame: Baseline and weeks 4, 8 and 12
measure: Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Patient Global Impression of Change at Weeks 4, 8 and 12
timeFrame: Weeks 4, 8, and 12
measure: Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved
timeFrame: Weeks 4, 8, and 12
measure: Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved
timeFrame: Weeks 4, 8, and 12
measure: Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24
timeFrame: Baseline and Week 24
measure: Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: