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: April 4, 2014
Last verified: April 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: September 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760954

  Show 139 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: April 4, 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 April 22, 2014