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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01620528
First received: May 15, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Endometriosis
Drug: Elagolix
Other: placebo
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: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the 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: Baseline ] [ Designated as safety issue: No ]
  • Endometriosis Associated Pain [ Time Frame: Month 3 of Treatment Period ] [ Designated as safety issue: No ]
    Proportion of responders based reduction from baseline.

  • Endometriosis Associated Pain [ Time Frame: Month 6 of Treatment Period ] [ Designated as safety issue: No ]
    Proportion of responders based reduction from baseline.

  • Bone Mineral Density (DXA Scan) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 6 of Treatment Period ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 6 of Follow-Up Period ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Bone Mineral Density (DXA Scan) [ Time Frame: Month 12 of Follow-Up Period ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Endometrial Biopsy; Assessment of significant endometrial biopsy findings at baseline [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Percent of subjects in each diagnostic category of biopsy result

  • Transvaginal Ultrasound (TVU); Assessment of significant TVU findings at baseline [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Change from baseline in endometrial thickness; percent of subjects with ovarian cyst


Secondary Outcome Measures:
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 1 of Treatment Period ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 2 of Treatment Period ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 3 of Treatment Period ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 4 of Treatment Period ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 5 of Treatment Period ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 6 of Treatment Period ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 1 of Follow-up Period ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Clinical Laboratory Tests (Hematology, Chemistry, Urinalysis and Endocrine Panel) [ Time Frame: Month 3 of Follow-up Period ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • 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: 875
Study Start Date: May 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders 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.
  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: NCT01620528

  Show 180 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Jean Rowan, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01620528     History of Changes
Other Study ID Numbers: M12-665
Study First Received: May 15, 2012
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 20, 2014