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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01760954
First received: January 2, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Endometriosis
Drug: Elagolix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extension Study to Evaluate the Long-Term 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:
  • Endometriosis Associated Pain [ Time Frame: Month 6 of Treatment Period ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Change from baseline in study M12-665 (NCT01620528)

  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 6 of Follow-up Period ] [ Designated as safety issue: Yes ]
    Change from baseline in study M12-665 (NCT01620528)

  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 12 of Follow-up Period ] [ Designated as safety issue: Yes ]
    Change from baseline in study M12-665 (NCT01620528)

  • Endometrial Biopsy [ Time Frame: Month 6 of Treatment Period ] [ Designated as safety issue: Yes ]
    Percent of subjects in each diagnostic category

  • Transvaginal Ultrasound (TVU) [ Time Frame: Month 6 of Treatment Period ] [ Designated as safety issue: Yes ]
    Change from baseline in study M12-665 (NCT01620528) in endometrial thickness; percent of subjects with ovarian cyst.


Secondary Outcome Measures:
  • Clinical Laboratory Tests (standard laboratory values including hormones) [ Time Frame: Month 3 of Treatment Period ] [ Designated as safety issue: Yes ]
    Change from baseline in study M12-665 (NCT01620528)

  • Clinical Laboratory Tests (standard laboratory values including hormones) [ Time Frame: Month 6 of Treatment Period ] [ Designated as safety issue: Yes ]
    Change from baseline in study M12-665 (NCT01620528)

  • Clinical Laboratory Tests (standard laboratory values including hormones) [ Time Frame: Month 3 of Follow-up Period ] [ Designated as safety issue: Yes ]
    Change from baseline in study M12-665 (NCT01620528)

  • Number of study subjects with Adverse Events [ Time Frame: Up to Month 18 ] [ Designated as safety issue: Yes ]
    Proportion of subjects reporting Adverse Events


Estimated Enrollment: 500
Study Start Date: December 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elagolix Dose 1
Elagolix Dose 1
Drug: Elagolix
Two different doses with matching placebo in 2 different arms daily over a 6 month treatment period
Experimental: Elagolix Dose 2
Elagolix Dose 2
Drug: Elagolix
Two different doses with matching placebo in 2 different arms daily over a 6 month treatment period

Detailed Description:

This is a Phase 3 multicenter, double blind randomized study to assess the continued safety and efficacy of two doses of elagolix (Dose 1 and Dose 2) in premenopausal women with moderate to severe endometriosis-associated pain who completed the 6 month treatment period in the pivotal study M12-665 (NCT01620528). Approximately 500 subjects are expected to enroll at approximately up to 200 sites. The study consists of 2 periods: 1.) a 6 month Treatment Period and 2.) a post treatment Follow-up period of up to 12 months (if applicable). An electronic diary will be used to collect 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 contraceptive during the study and will be counsel on appropriate and effective forms of birth control to promote pregnancy prevention.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 gynecological 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
  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: NCT01760954

  Show 143 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: W. Rachel Duan, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01760954     History of Changes
Other Study ID Numbers: M12-667
Study First Received: January 2, 2013
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 16, 2014