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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:
ClinicalTrials.gov Identifier:
NCT01620528
First Posted: June 15, 2012
Last Update Posted: March 21, 2017
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.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
May 15, 2012
June 15, 2012
March 21, 2017
May 2012
November 2014   (Final data collection date for primary outcome measure)
  • 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
  • Endometriosis Associated Pain [ Time Frame: Baseline ]
  • Endometriosis Associated Pain [ Time Frame: Month 3 of Treatment Period ]
    Proportion of responders based reduction from baseline.
  • Endometriosis Associated Pain [ Time Frame: Month 6 of Treatment Period ]
    Proportion of responders based reduction from baseline.
  • Bone Mineral Density (DXA Scan) [ Time Frame: Baseline ]
  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 6 of Treatment Period ]
    Change from baseline
  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 6 of Follow-Up Period ]
    Change from Baseline
  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 12 of Follow-Up Period ]
    Change from Baseline
  • Endometrial Biopsy; Assessment of significant endometrial biopsy findings at baseline [ Time Frame: Baseline ]
    Assessment of significant endometrial biopsy findings (e.g., endometrial thickness, etc)
  • Endometrial Biopsy; Changes from baseline to final treatment in biopsy findings [ Time Frame: Month 6 of Treatment Period ]
    Percent of subjects in each diagnostic category of biopsy result
  • Transvaginal Ultrasound (TVU); Assessment of significant TVU findings at baseline [ Time Frame: Baseline ]
    Assessment of significant TVU finding (e.g., ovarian cyst, etc)
  • Transvaginal Ultrasound (TVU); Changes from baseline to final treatment in TVU findings [ Time Frame: Month 6 of Treatment Period ]
    Change from baseline in endometrial thickness; percent of subjects with ovarian cyst
Complete list of historical versions of study NCT01620528 on ClinicalTrials.gov Archive Site
  • 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
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Baseline ]
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 1 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 2 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 3 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 4 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 5 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 6 of Treatment Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 1 of Follow-up Period ]
    Change from Baseline
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 3 of Follow-up Period ]
    Change from Baseline
  • Number of study subjects with Adverse Events [ Time Frame: Up to Month 18 ]
    Proportion of subjects reporting adverse events
Not Provided
Not Provided
 
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Endometriosis
  • 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
  • Other: placebo
    Placebo for 6 Month Treatment Period
  • Experimental: Elagolix Dose 1
    Elagolix Dose 1
    Intervention: Drug: Elagolix
  • Experimental: Elagolix Dose 2
    Elagolix Dose 2
    Intervention: Drug: Elagolix
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: placebo
Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
872
September 2015
November 2014   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: Female
18 Years to 49 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Puerto Rico,   United States
 
 
NCT01620528
M12-665
Yes
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Rachel Duan, MD AbbVie
AbbVie
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP