Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00797225
• Date of registration: 21/11/2008
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis
• Scientific title: A Phase II, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis
• Date of first enrolment: November 26, 2008
• Target sample size: 174
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00797225
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Hungary, Poland, Romania, Russian Federation, Ukraine

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria

- Female, aged 18 to 45 years, inclusive

- Have moderate to severe pelvic pain due to endometriosis

- Have been surgically (laparoscopy) diagnosed with endometriosis within the last 5
years and have recurrent or persistent endometriosis symptoms

- Have regular menstrual cycle (23-33 day)

- Agree to use two forms of non-hormonal contraception during the study

Exclusion Criteria:

- Received a Gonadotropin-releasing hormone (GnRH) agonist, GnRH antagonist, danazol, or
have received any of these agents within 6 months of the start of screening.

- Received subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular (i.m.)
medroxyprogesterone acetate (DMPA-IM), or have received either 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

- Are using systemic steroids on a chronic or regular basis within 3 months

- Have uterine fibroids or other pelvic lesions = 3 cm in diameter

- Have had a hysterectomy or oophorectomy

- Have pelvic pain that is not caused by endometriosis

- Have unstable medical condition or chronic disease

- Have been pregnant within the last 6 months and is currently breast feeding



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Endometriosis

Intervention(s)

Drug: Elagolix

Drug: Leuprorelin Acetate Depot

Drug: Placebo to Elagolix

Drug: Placebo to Leuprorelin Acetate

Primary Outcome(s)

Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain [Time Frame: Baseline and Weeks 4, 8, and 12]

Secondary Outcome(s)

Average Number of Hot Flashes Per Day [Time Frame: Screening (8 weeks prior to day 1), Treatment phase (weeks 1 to 12 for participants in the placebo and leuprorelin treatment groups and weeks 1 to 24 for participants in the elagolix treatment groups)]

Change From Baseline in the Percentage of Days of Any Analgesic Use [Time Frame: Baseline, Weeks 4, 8 and 12]

Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12 [Time Frame: Baseline and week 12]

Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved [Time Frame: Weeks 4, 8 and 12]

Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) [Time Frame: Baseline and Weeks 4, 8, and 12]

Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12 [Time Frame: Baseline and week 12]

Change From Baseline in Serum N-telopeptide Concentration at Week 12 [Time Frame: Baseline and week 12]

Number of Days to First Posttreatment Menses [Time Frame: From last day of study drug up to 6 weeks after the last dose.]

Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved [Time Frame: Weeks 4, 8 and 12]

Change From Baseline in the Monthly Mean Dysmenorrhea Score [Time Frame: Baseline and Weeks 4, 8, and 12]

Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score [Time Frame: Baseline and Weeks 4, 8, and 12]

Change From Baseline in Dysmenorrhea Component of the CPSSS [Time Frame: Baseline and Week 12]

Change From Baseline in the Percentage of Days of Prescription Analgesic Use [Time Frame: Baseline, Weeks 4, 8 and 12]

Change From Baseline in the Monthly Mean Sum of Dysmenorrhea and Non-menstrual Pelvic Pain Scores [Time Frame: Baseline and Weeks 4, 8, and 12]

Percentage of Days With Uterine Bleeding [Time Frame: Screening (8 weeks prior to day 1), Treatment phase (weeks 1 to 12 for participants in the placebo and leuprorelin treatment groups and weeks 1 to 24 for participants in the elagolix treatment groups)]

Change From Baseline in Non-menstrual Pelvic Pain CPSSS Component [Time Frame: Baseline and Week 12]

Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain [Time Frame: Baseline and Weeks 4, 8, and 12]

Change From Baseline in the Percentage of Days of Narcotic Analgesic Use [Time Frame: Baseline, Weeks 4, 8 and 12]

Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12 [Time Frame: Baseline and week 12]

Concentration of Serum Estradiol [Time Frame: Baseline and Weeks 4, 8 and 12]

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

Patient Global Impression of Change at Weeks 4, 8 and 12 [Time Frame: Weeks 4, 8 and 12]

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

Secondary ID(s)

NBI-56418-0703

2007-006474-28

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00797225