ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01620528
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01620528
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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 or disease Intervention/treatment Phase
Endometriosis Drug: Elagolix Other: placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 872 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : May 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
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




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

  2. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

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

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

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

  10. 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

  11. 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

  12. 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

  13. 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

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

  15. 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

  16. 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

  17. 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

  18. 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

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

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

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

  22. 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

  23. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620528


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01620528     History of Changes
Other Study ID Numbers: M12-665
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female