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A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01620528
First received: May 15, 2012
Last updated: March 18, 2017
Last verified: March 2017
  Purpose
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.

Condition Intervention Phase
Endometriosis
Drug: Elagolix
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of responders based on daily assessment of dysmenorrhea (DYS) [ Time Frame: At Month 3 of the Treatment Period ]
    via eDiary

  • Proportion of responders based on daily assessment of non-menstrual pelvic pain (NMPP) [ Time Frame: At Month 3 of Treatment Period ]
    via eDiary


Secondary Outcome Measures:
  • Change from baseline to each month in numeric rating scale (NRS) scores [ Time Frame: From baseline (prior to study drug administration) to Month 3 of the Treatment Period ]
    via eDiary

  • Change from baseline to each month in dysmenorrhea (DYS) [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each month in non-menstrual pelvic pain (NMPP) [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline in analgesic use across both classes of rescue analgesics based on pill counts [ Time Frame: Change from baseline (prior to study drug administration) to Month 3 and Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each month in dyspareunia [ Time Frame: From baseline (prior to study drug administration) to Month 3 of Treatment Period ]
    via eDiary

  • Change from baseline in use of narcotic class of medication based on pill counts [ Time Frame: From baseline (prior to study drug administration) to Month 3 of Treatment Period ]
    via eDiary

  • Proportion of responders for each month, except Month 3, in DYS [ Time Frame: Up to Month 6 of Treatment Period ]
    via eDiary

  • Proportion of responders for each month, except Month 3, in NMPP [ Time Frame: Up to Month 6 of Treatment Period ]
    via eDiary

  • Proportion of responders at each month for dyspareunia [ Time Frame: Up to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each month, except Month 6, in the mean pain score for DYS [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each month, except Month 6, in the mean pain score for NMPP [ Time Frame: From baseline (prior to study drug administration) to Month 6 ]
    via eDiary

  • Change from baseline to each month, except Month 3, in the mean pain score of dyspareunia [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each month, except Months 3 and 6, in analgesic use across both classes of rescue analgesics to treat endometriosis-related pain [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Response at each month to Patient Global Impression of Change (PGIC) [ Time Frame: Up to Month 6 of Treatment Period ]
    PGIC questionnaire

  • Change from baseline to each month, except Month 3, in NRS scores [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each scheduled assessment in the scores in the pain domain of the Endometriosis Health Profile-30 (EHP-30) [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    EHP-30 questionnaire

  • Change from baseline to each scheduled assessment in the scores in the sexual relationship domain of the Endometriosis Health Profile-30 (EHP-30) [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    EHP-30 questionnaire

  • Change from baseline to each scheduled assessment in Health Related Productivity Questionnaire (HRPQ) scores [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    HRPQ

  • Number of endometriosis-related non-study health visits [ Time Frame: Up to Month 6 of Treatment Period ]
    HRPQ

  • Number of days in hospital [ Time Frame: Up to Month 6 of Treatment Period ]
    HRPQ

  • Type of procedures performed [ Time Frame: Up to Month 6 of Treatment Period ]
    HRPQ

  • Percent change from baseline to each month in the mean pain score for DYS [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Percent change from baseline to each month in the mean pain score for NMPP [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary


Enrollment: 872
Study Start Date: May 2012
Study Completion Date: September 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elagolix Dose 1
Elagolix Dose 1
Drug: Elagolix
Elagolix Dose 1 for 6 month Treatment Period, Elagolix Dose 2 for the 6 month Treatment Period
Other Name: ABT-620, elagolix sodium
Experimental: Elagolix Dose 2
Elagolix Dose 2
Drug: Elagolix
Elagolix Dose 1 for 6 month Treatment Period, Elagolix Dose 2 for the 6 month Treatment Period
Other Name: ABT-620, elagolix sodium
Placebo Comparator: Placebo
Placebo
Other: placebo
Placebo for 6 Month Treatment Period

Detailed Description:
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix (Dose 1 and Dose 2) versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. Approximately 875 subjects will be enrolled into the study at approximately 160 sites. The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study. Subjects will be required to use non-hormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.
  Eligibility

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: 1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.

2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into the Washout Period.

3. Agrees to use required birth control methods during the entire length of participation in the study.

4. Subject has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5. Subjects must have at least two menstrual cycles 24 to 38 days within the Screening Period, prior to Day 1 Exclusion Criteria: 1. Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.

2. Subject has a history of previous non-response to GnRH agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary).

3. Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.

4. Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.

5. Subject has a history of osteoporosis or other metabolic bone disease. 6. Subject has a current history of undiagnosed abnormal genital bleeding.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620528

  Show 179 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Rachel Duan, MD AbbVie
  More Information

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01620528     History of Changes
Other Study ID Numbers: M12-665
Study First Received: May 15, 2012
Last Updated: March 18, 2017

Keywords provided by AbbVie:
Gonadotropin-Releasing Hormone Antagonist
Endometriosis associated pain
Dysmenorrhea (DYS)
Non-Menstrual Pelvic Pain (NMPP)
Elagolix

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on March 28, 2017