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

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ClinicalTrials.gov Identifier: NCT01760954
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

January 2, 2013
January 4, 2013
January 5, 2018
December 2012
May 2015   (Final data collection date for primary outcome measure)
  • Proportion of responders at Month 6 based on daily assessment of dysmenorrhea (DYS) [ Time Frame: At Month 6 of the Treatment Period ]
    via e-Diary
  • Proportion of responders at Month 6 based on daily assessment of non-menstrual pelvic pain (NMPP) [ Time Frame: At Month 6 of the Treatment Period ]
    via e-Diary
  • Endometriosis Associated Pain [ Time Frame: Month 6 of Treatment Period ]
    Proportion of responders based on reduction from baseline in study M12-665 (NCT01620528)
  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 6 of Treatment Period ]
    Change from baseline in study M12-665 (NCT01620528)
  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 6 of Follow-up Period ]
    Change from baseline in study M12-665 (NCT01620528)
  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 12 of Follow-up Period ]
    Change from baseline in study M12-665 (NCT01620528)
  • Endometrial Biopsy [ Time Frame: Month 6 of Treatment Period ]
    Percent of subjects in each diagnostic category
  • Transvaginal Ultrasound (TVU) [ Time Frame: Month 6 of Treatment Period ]
    Change from baseline in study M12-665 (NCT01620528) in endometrial thickness; percent of subjects with ovarian cyst.
Complete list of historical versions of study NCT01760954 on ClinicalTrials.gov Archive Site
  • 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 in dysmenorrhea (DYS) [ Time Frame: Up 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 to each month in dyspareunia [ Time Frame: From Baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary
  • Change from baseline to each month in analgesic use to treat endometriosis-related pain [ Time Frame: From Baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary
  • Results of Endometriosis Health Profile-30 (EHP-30) domain of pain at each assessed visit [ Time Frame: Up to Month 6 of Treatment Period ]
    EHP-30 questionnaire
  • Results of EHP-30 domain of sexual relationship at each assessed visit [ Time Frame: Up to Month 6 of Treatment Period ]
    EHP-30 questionnaire
  • Summary of Health Related Productivity Questionnaire (HRPQ) scores by visit [ Time Frame: Up to Month 6 of Treatment Period ]
    HRPQ
  • Number of endometriosis-related non-study health visits [ Time Frame: Up to Month 6 of Treatment Period ]
    Health Resource Utilization Questionnaire (HRUQ)
  • Number of days in hospital [ Time Frame: Up to Month 6 of Treatment Period ]
    HRUQ
  • Type of procedures performed [ Time Frame: Up to Month 6 of Treatment Period ]
    HRUQ
  • Change from baseline to each month in Numeric Rating Scale (NRS) scores [ Time Frame: Up to Month 6 of Treatment Period ]
    via eDiary
  • Response at each month to the Patient Global Impression of Change (PGIC) questionnaire [ Time Frame: Up to Month 6 of Treatment Period ]
    PGIC questionnaire
  • Clinical Laboratory Tests (standard laboratory values including hormones) [ Time Frame: Month 3 of Treatment Period ]
    Change from baseline in study M12-665 (NCT01620528)
  • Clinical Laboratory Tests (standard laboratory values including hormones) [ Time Frame: Month 6 of Treatment Period ]
    Change from baseline in study M12-665 (NCT01620528)
  • Clinical Laboratory Tests (standard laboratory values including hormones) [ Time Frame: Month 3 of Follow-up Period ]
    Change from baseline in study M12-665 (NCT01620528)
  • Number of study subjects with Adverse Events [ Time Frame: Up to Month 18 ]
    Proportion of subjects reporting Adverse Events
Not Provided
Not Provided
 
Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult pre-menopausal female subjects who completed the 6 month treatment period in the pivotal study M12-665.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Endometriosis
  • Drug: Elagolix
  • Other: Placebo
    (To maintain blind)
  • Experimental: Elagolix Dose 1
    Elagolix dose 1 for 6 month treatment period.
    Interventions:
    • Drug: Elagolix
    • Other: Placebo
  • Experimental: Elagolix Dose 2
    Elagolix dose 2 for 6 month treatment period.
    Intervention: Drug: Elagolix
Surrey E, Taylor HS, Giudice L, Lessey BA, Abrao MS, Archer DF, Diamond MP, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Singh SS, Rechberger T, Agarwal SK, Duan WR, Schwefel B, Thomas JW, Peloso PM, Ng J, Soliman AM, Chwalisz K. Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension Studies. Obstet Gynecol. 2018 Jul;132(1):147-160. doi: 10.1097/AOG.0000000000002675.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
506
500
March 2016
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528)
  • Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period

Exclusion Criteria:

  • Clinically significant condition
  • Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip
  • Plans to become pregnant in the next 18 months
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Puerto Rico,   United States
 
 
NCT01760954
M12-667
Yes
Not Provided
Not Provided
AbbVie
AbbVie
Not Provided
Study Director: Rachel W Duan, MD AbbVie
AbbVie
January 2018

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