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

This study is currently recruiting participants.
Verified April 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01620528
First received: May 15, 2012
Last updated: April 9, 2014
Last verified: April 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: August 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620528

Contacts
Contact: Cynthia Mattia-Goldberg, MS 847-938-1460 cynthia.mattia-goldberg@abbvie.com
Contact: Sheilah Smok-Pearsall, BS 847-938-5764 sheilah.smok-pearsall@abbvie.com

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 51487 Active, not recruiting
Birmingham, Alabama, United States, 35235
Site Reference ID/Investigator# 87953 Recruiting
Cullman, Alabama, United States, 35058
Principal Investigator: Site Reference ID/Investigator# 87953         
Site Reference ID/Investigator# 64270 Active, not recruiting
Mobile, Alabama, United States, 36608
Site Reference ID/Investigator# 81473 Withdrawn
Montgomery, Alabama, United States, 36106
Site Reference ID/Investigator# 103736 Withdrawn
Montgomery, Alabama, United States, 36117
United States, Arizona
Site Reference ID/Investigator# 50717 Recruiting
Chandler, Arizona, United States, 85224
Principal Investigator: Site Reference ID/Investigator# 50717         
Site Reference ID/Investigator# 53029 Active, not recruiting
Chandler, Arizona, United States, 85225
Site Reference ID/Investigator# 89634 Active, not recruiting
Goodyear, Arizona, United States, 85395
Site Reference ID/Investigator# 50222 Active, not recruiting
Phoenix, Arizona, United States, 85015
Site Reference ID/Investigator# 63980 Completed
Phoenix, Arizona, United States, 85023
Site Reference ID/Investigator# 75493 Active, not recruiting
Tucson, Arizona, United States, 85710
Site Reference ID/Investigator# 50261 Completed
Tucson, Arizona, United States, 85712
United States, Arkansas
Site Reference ID/Investigator# 50688 Active, not recruiting
Little Rock, Arkansas, United States, 72205
Site Reference ID/Investigator# 82573 Recruiting
Little Rock, Arkansas, United States, 72204
Principal Investigator: Site Reference ID/Investigator# 82573         
United States, California
Site Reference ID/Investigator# 78653 Withdrawn
Anaheim, California, United States, 92801
Site Reference ID/Investigator# 102895 Recruiting
Artesia, California, United States, 90701
Principal Investigator: Site Reference ID/Investigator# 102895         
Site Reference ID/Investigator# 53034 Active, not recruiting
Carmichael, California, United States, 95608
Site Reference ID/Investigator# 96747 Active, not recruiting
Chino, California, United States, 91710
Site Reference ID/Investigator# 73673 Recruiting
Davis, California, United States, 95616
Principal Investigator: Site Reference ID/Investigator# 73673         
Site Reference ID/Investigator# 50669 Active, not recruiting
Encinitas, California, United States, 92024
Site Reference ID/Investigator# 56602 Recruiting
La Jolla, California, United States, 92093-0633
Principal Investigator: Site Reference ID/Investigator# 56602         
Site Reference ID/Investigator# 74793 Recruiting
Los Angeles, California, United States, 90036
Principal Investigator: Site Reference ID/Investigator# 74793         
Site Reference ID/Investigator# 69583 Recruiting
Redondo Beach, California, United States, 90277
Principal Investigator: Site Reference ID/Investigator# 69583         
Site Reference ID/Investigator# 50247 Completed
San Diego, California, United States, 92103
Site Reference ID/Investigator# 50715 Completed
San Diego, California, United States, 92101
Site Reference ID/Investigator# 50227 Recruiting
San Diego, California, United States, 92108
Principal Investigator: Site Reference ID/Investigator# 50227         
Site Reference ID/Investigator# 50691 Withdrawn
San Francisco, California, United States, 94115
Site Reference ID/Investigator# 79813 Completed
Walnut Creek, California, United States, 94598
United States, Colorado
Site Reference ID/Investigator# 65748 Recruiting
Colorado Springs, Colorado, United States, 80906
Principal Investigator: Site Reference ID/Investigator# 65748         
Site Reference ID/Investigator# 50220 Recruiting
Colorado Springs, Colorado, United States, 80910
Principal Investigator: Site Reference ID/Investigator# 50220         
Site Reference ID/Investigator# 53824 Active, not recruiting
Denver, Colorado, United States, 80246
Site Reference ID/Investigator# 50254 Recruiting
Denver, Colorado, United States, 80209
Principal Investigator: Site Reference ID/Investigator# 50254         
Site Reference ID/Investigator# 50263 Recruiting
Lakewood, Colorado, United States, 80228
Principal Investigator: Site Reference ID/Investigator# 50263         
Site Reference ID/Investigator# 64623 Recruiting
Lonetree, Colorado, United States, 80124
Principal Investigator: Site Reference ID/Investigator# 64623         
United States, Connecticut
Site Reference ID/Investigator# 74974 Completed
Danbury, Connecticut, United States, 06810
Site Reference ID/Investigator# 53822 Recruiting
Groton, Connecticut, United States, 06340
Principal Investigator: Site Reference ID/Investigator# 53822         
Site Reference ID/Investigator# 53130 Completed
Hartford, Connecticut, United States, 06105
Site Reference ID/Investigator# 50230 Active, not recruiting
New Britain, Connecticut, United States, 06050
Site Reference ID/Investigator# 71916 Recruiting
New Haven, Connecticut, United States, 06510-8063
Principal Investigator: Site Reference ID/Investigator# 71916         
Site Reference ID/Investigator# 50709 Recruiting
New London, Connecticut, United States, 06320
Principal Investigator: Site Reference ID/Investigator# 50709         
Site Reference ID/Investigator# 53131 Withdrawn
West Hartford, Connecticut, United States, 06117
United States, Florida
Site Reference ID/Investigator# 50205 Active, not recruiting
Boynton Beach, Florida, United States, 33472
Site Reference ID/Investigator# 58063 Recruiting
Clearwater, Florida, United States, 33765
Principal Investigator: Site Reference ID/Investigator# 58063         
Site Reference ID/Investigator# 74978 Recruiting
Clearwater, Florida, United States, 33759
Principal Investigator: Site Reference ID/Investigator# 74978         
Site Reference ID/Investigator# 59941 Recruiting
Debary, Florida, United States, 32713
Principal Investigator: Site Reference ID/Investigator# 59941         
Site Reference ID/Investigator# 61830 Recruiting
Fort Lauderdale, Florida, United States, 33316
Principal Investigator: Site Reference ID/Investigator# 61830         
Site Reference ID/Investigator# 64268 Completed
Fort Lauderdale, Florida, United States, 33328
Site Reference ID/Investigator# 96746 Recruiting
Fort Myers, Florida, United States, 33916
Principal Investigator: Site Reference ID/Investigator# 96746         
Site Reference ID/Investigator# 74977 Active, not recruiting
Gainesville, Florida, United States, 32607
Site Reference ID/Investigator# 118415 Recruiting
Hialeah, Florida, United States, 33012
Principal Investigator: Site Reference ID/Investigator# 118415         
Site Reference ID/Investigator# 89953 Recruiting
Miami, Florida, United States, 33126
Principal Investigator: Site Reference ID/Investigator# 89953         
Site Reference ID/Investigator# 78475 Withdrawn
Miami, Florida, United States, 33015
Site Reference ID/Investigator# 102575 Recruiting
Miami Lakes, Florida, United States, 33014
Principal Investigator: Site Reference ID/Investigator# 102575         
Site Reference ID/Investigator# 50248 Active, not recruiting
New Port Richey, Florida, United States, 34652
Site Reference ID/Investigator# 57845 Completed
New Port Richey, Florida, United States, 34652
Site Reference ID/Investigator# 50687 Completed
North Miami, Florida, United States, 33161
Site Reference ID/Investigator# 69584 Recruiting
Plantation, Florida, United States, 33324
Principal Investigator: Site Reference ID/Investigator# 69584         
Site Reference ID/Investigator# 53826 Recruiting
Sarasota, Florida, United States, 34239
Principal Investigator: Site Reference ID/Investigator# 53826         
Site Reference ID/Investigator# 115096 Withdrawn
South Miami, Florida, United States, 33143
Site Reference ID/Investigator# 50240 Active, not recruiting
Tampa, Florida, United States, 33606
Site Reference ID/Investigator# 51492 Recruiting
West Palm Beach, Florida, United States, 33409
Principal Investigator: Site Reference ID/Investigator# 51492         
United States, Georgia
Site Reference ID/Investigator# 56605 Recruiting
Augusta, Georgia, United States, 30909
Principal Investigator: Site Reference ID/Investigator# 56605         
Site Reference ID/Investigator# 69422 Completed
Augusta, Georgia, United States, 30909
Site Reference ID/Investigator# 69936 Withdrawn
Decatur, Georgia, United States, 30035
Site Reference ID/Investigator# 50209 Recruiting
Sandy Springs, Georgia, United States, 30328
Principal Investigator: Site Reference ID/Investigator# 50209         
Site Reference ID/Investigator# 75494 Withdrawn
Savannah, Georgia, United States, 31406
Site Reference ID/Investigator# 82575 Active, not recruiting
Savannah, Georgia, United States, 31406
United States, Idaho
Site Reference ID/Investigator# 100735 Withdrawn
Blackfoot, Idaho, United States, 83221
Site Reference ID/Investigator# 54685 Recruiting
Boise, Idaho, United States, 83712
Principal Investigator: Site Reference ID/Investigator# 54685         
Site Reference ID/Investigator# 50258 Active, not recruiting
Idaho Falls, Idaho, United States, 83404
Site Reference ID/Investigator# 92214 Withdrawn
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Site Reference ID/Investigator# 50249 Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Site Reference ID/Investigator# 50249         
Site Reference ID/Investigator# 78634 Recruiting
Chicago, Illinois, United States, 60616
Principal Investigator: Site Reference ID/Investigator# 78634         
Site Reference ID/Investigator# 50216 Recruiting
Oak Brook, Illinois, United States, 60523
Principal Investigator: Site Reference ID/Investigator# 50216         
Site Reference ID/Investigator# 50232 Withdrawn
Schaumburg, Illinois, United States, 60173
United States, Indiana
Site Reference ID/Investigator# 80754 Active, not recruiting
Avon, Indiana, United States, 46123
Site Reference ID/Investigator# 58062 Recruiting
Granger, Indiana, United States, 46530
Principal Investigator: Site Reference ID/Investigator# 58062         
United States, Iowa
Site Reference ID/Investigator# 69934 Recruiting
West Des Moines, Iowa, United States, 50266
Principal Investigator: Site Reference ID/Investigator# 69934         
United States, Kansas
Site Reference ID/Investigator# 81733 Recruiting
Shawnee, Kansas, United States, 66218
Principal Investigator: Site Reference ID/Investigator# 81733         
United States, Kentucky
Site Reference ID/Investigator# 81734 Recruiting
Lexington, Kentucky, United States, 40509
Principal Investigator: Site Reference ID/Investigator# 81734         
Site Reference ID/Investigator# 115015 Withdrawn
Lexington, Kentucky, United States, 40509
Site Reference ID/Investigator# 93573 Recruiting
Owensboro, Kentucky, United States, 43203
Principal Investigator: Site Reference ID/Investigator# 93573         
United States, Louisiana
Site Reference ID/Investigator# 53032 Active, not recruiting
Marrero, Louisiana, United States, 70072
Site Reference ID/Investigator# 89315 Recruiting
New Orleans, Louisiana, United States, 70112
Principal Investigator: Site Reference ID/Investigator# 89315         
Site Reference ID/Investigator# 50714 Recruiting
New Orleans, Louisiana, United States, 70115
Principal Investigator: Site Reference ID/Investigator# 50714         
United States, Maryland
Site Reference ID/Investigator# 59063 Completed
Frederick, Maryland, United States, 21702
United States, Massachusetts
Site Reference ID/Investigator# 62226 Recruiting
Brookline, Massachusetts, United States, 02446
Principal Investigator: Site Reference ID/Investigator# 62226         
Site Reference ID/Investigator# 74715 Completed
Worcester, Massachusetts, United States, 01605
United States, Michigan
Site Reference ID/Investigator# 50262 Recruiting
Ann Arbor, Michigan, United States, 48106
Principal Investigator: Site Reference ID/Investigator# 50262         
Site Reference ID/Investigator# 63149 Recruiting
Bay City, Michigan, United States, 48706
Principal Investigator: Site Reference ID/Investigator# 63149         
Site Reference ID/Investigator# 50671 Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Site Reference ID/Investigator# 50671         
Site Reference ID/Investigator# 65903 Withdrawn
Detroit, Michigan, United States, 48201
Site Reference ID/Investigator# 50207 Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: Site Reference ID/Investigator# 50207         
Site Reference ID/Investigator# 71716 Withdrawn
Kalamazoo, Michigan, United States, 49009
Site Reference ID/Investigator# 50718 Recruiting
Saginaw, Michigan, United States, 48604
Principal Investigator: Site Reference ID/Investigator# 50718         
United States, Minnesota
Site Reference ID/Investigator# 50696 Recruiting
Chaska, Minnesota, United States, 55318
Principal Investigator: Site Reference ID/Investigator# 50696         
United States, Missouri
Site Reference ID/Investigator# 73793 Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Site Reference ID/Investigator# 73793         
United States, Montana
Site Reference ID/Investigator# 50678 Recruiting
Billings, Montana, United States, 59101
Principal Investigator: Site Reference ID/Investigator# 50678         
Site Reference ID/Investigator# 50260 Completed
Missoula, Montana, United States, 59808
United States, Nebraska
Site Reference ID/Investigator# 50264 Active, not recruiting
Lincoln, Nebraska, United States, 68510
Site Reference ID/Investigator# 65902 Active, not recruiting
Omaha, Nebraska, United States, 68124
United States, Nevada
Site Reference ID/Investigator# 50984 Completed
Las Vegas, Nevada, United States, 89128
Site Reference ID/Investigator# 70594 Recruiting
Las Vegas, Nevada, United States, 89113
Principal Investigator: Site Reference ID/Investigator# 70594         
Site Reference ID/Investigator# 75497 Recruiting
Las Vegas, Nevada, United States, 89106
Principal Investigator: Site Reference ID/Investigator# 75497         
Site Reference ID/Investigator# 53028 Recruiting
Sparks, Nevada, United States, 89434
Principal Investigator: Site Reference ID/Investigator# 53028         
United States, New Jersey
Site Reference ID/Investigator# 97396 Recruiting
Jersey City, New Jersey, United States, 07306
Principal Investigator: Site Reference ID/Investigator# 97396         
Site Reference ID/Investigator# 64272 Completed
Lawrenceville, New Jersey, United States, 08648
Site Reference ID/Investigator# 50218 Recruiting
Plainsboro, New Jersey, United States, 08536
Principal Investigator: Site Reference ID/Investigator# 50218         
United States, New Mexico
Site Reference ID/Investigator# 53762 Recruiting
Albuquerque, New Mexico, United States, 87109
Principal Investigator: Site Reference ID/Investigator# 53762         
Site Reference ID/Investigator# 65743 Completed
Albuquerque, New Mexico, United States, 87102
United States, New York
Site Reference ID/Investigator# 72895 Recruiting
Bronx, New York, United States, 10467
Principal Investigator: Site Reference ID/Investigator# 72895         
Site Reference ID/Investigator# 59062 Recruiting
Brooklyn, New York, United States, 11203
Principal Investigator: Site Reference ID/Investigator# 59062         
Site Reference ID/Investigator# 80753 Recruiting
New York, New York, United States, 10038
Principal Investigator: Site Reference ID/Investigator# 80753         
Site Reference ID/Investigator# 57838 Active, not recruiting
Port Jefferson, New York, United States, 11777
Site Reference ID/Investigator# 77473 Recruiting
Staten Island, New York, United States, 10306
Principal Investigator: Site Reference ID/Investigator# 77473         
United States, North Carolina
Site Reference ID/Investigator# 65983 Recruiting
Charlotte, North Carolina, United States, 28209
Principal Investigator: Site Reference ID/Investigator# 65983         
Site Reference ID/Investigator# 60483 Active, not recruiting
Durham, North Carolina, United States, 27713
Site Reference ID/Investigator# 69935 Recruiting
Greensboro, North Carolina, United States, 27408
Principal Investigator: Site Reference ID/Investigator# 69935         
Site Reference ID/Investigator# 50705 Recruiting
New Bern, North Carolina, United States, 28562
Principal Investigator: Site Reference ID/Investigator# 50705         
Site Reference ID/Investigator# 50666 Active, not recruiting
Raleigh, North Carolina, United States, 27612
Site Reference ID/Investigator# 52922 Withdrawn
Salisbury, North Carolina, United States, 28144
Site Reference ID/Investigator# 53031 Active, not recruiting
Winston-Salem, North Carolina, United States, 27103
Site Reference ID/Investigator# 50224 Recruiting
Winston-Salem, North Carolina, United States, 27103
Principal Investigator: Site Reference ID/Investigator# 50224         
Site Reference ID/Investigator# 71719 Completed
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Site Reference ID/Investigator# 50674 Recruiting
Bismarck, North Dakota, United States, 58501
Principal Investigator: Site Reference ID/Investigator# 50674         
Site Reference ID/Investigator# 78474 Active, not recruiting
Minot, North Dakota, United States, 58701
United States, Ohio
Site Reference ID/Investigator# 53135 Active, not recruiting
Akron, Ohio, United States, 44311
Site Reference ID/Investigator# 53027 Recruiting
Akron, Ohio, United States, 44313
Principal Investigator: Site Reference ID/Investigator# 53027         
Site Reference ID/Investigator# 83013 Active, not recruiting
Cincinnati, Ohio, United States, 45267-0457
Site Reference ID/Investigator# 69585 Recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Site Reference ID/Investigator# 69585         
Site Reference ID/Investigator# 66584 Recruiting
Columbus, Ohio, United States, 43231
Principal Investigator: Site Reference ID/Investigator# 66584         
Site Reference ID/Investigator# 53025 Recruiting
Columbus, Ohio, United States, 43212
Principal Investigator: Site Reference ID/Investigator# 53025         
Site Reference ID/Investigator# 50242 Recruiting
Columbus, Ohio, United States, 43213
Principal Investigator: Site Reference ID/Investigator# 50242         
Site Reference ID/Investigator# 60863 Recruiting
Mayfield Heights, Ohio, United States, 44124
Principal Investigator: Site Reference ID/Investigator# 60863         
United States, Oklahoma
Site Reference ID/Investigator# 50257 Active, not recruiting
Edmond, Oklahoma, United States, 73013
United States, Oregon
Site Reference ID/Investigator# 50208 Completed
Eugene, Oregon, United States, 97401
Site Reference ID/Investigator# 56704 Active, not recruiting
Medford, Oregon, United States, 97504
Site Reference ID/Investigator# 50252 Recruiting
Medford, Oregon, United States, 97504
Principal Investigator: Site Reference ID/Investigator# 50252         
Site Reference ID/Investigator# 56702 Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Site Reference ID/Investigator# 56702         
Site Reference ID/Investigator# 50706 Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Site Reference ID/Investigator# 50706         
United States, Pennsylvania
Site Reference ID/Investigator# 50684 Recruiting
Jenkintown, Pennsylvania, United States, 19046
Principal Investigator: Site Reference ID/Investigator# 50684         
Site Reference ID/Investigator# 50259 Recruiting
Philadelphia, Pennsylvania, United States, 19102
Principal Investigator: Site Reference ID/Investigator# 50259         
Site Reference ID/Investigator# 50204 Withdrawn
Philadelphia, Pennsylvania, United States, 19114
Site Reference ID/Investigator# 59082 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Site Reference ID/Investigator# 59082         
Site Reference ID/Investigator# 77658 Recruiting
Pittsburgh, Pennsylvania, United States, 15206
Principal Investigator: Site Reference ID/Investigator# 77658         
Site Reference ID/Investigator# 55105 Completed
Upper St. Clair, Pennsylvania, United States, 15241
Site Reference ID/Investigator# 53023 Recruiting
West Reading, Pennsylvania, United States, 19611
Principal Investigator: Site Reference ID/Investigator# 53023         
United States, South Carolina
Site Reference ID/Investigator# 82574 Recruiting
Bluffton, South Carolina, United States, 29910
Principal Investigator: Site Reference ID/Investigator# 82574         
Site Reference ID/Investigator# 71717 Completed
Columbia, South Carolina, United States, 29201
Site Reference ID/Investigator# 64622 Recruiting
Greenville, South Carolina, United States, 29605
Principal Investigator: Site Reference ID/Investigator# 64622         
Site Reference ID/Investigator# 50221 Recruiting
Greenville, South Carolina, United States, 29615
Principal Investigator: Site Reference ID/Investigator# 50221         
Site Reference ID/Investigator# 50983 Recruiting
Myrtle Beach, South Carolina, United States, 29572
Principal Investigator: Site Reference ID/Investigator# 50983         
Site Reference ID/Investigator# 75496 Completed
North Charleston, South Carolina, United States, 29406
United States, Tennessee
Site Reference ID/Investigator# 50245 Recruiting
Bristol, Tennessee, United States, 37620
Principal Investigator: Site Reference ID/Investigator# 50245         
Site Reference ID/Investigator# 53022 Completed
Chattanooga, Tennessee, United States, 37411
Site Reference ID/Investigator# 64275 Recruiting
Chattanooga, Tennessee, United States, 37404
Principal Investigator: Site Reference ID/Investigator# 64275         
Site Reference ID/Investigator# 50673 Active, not recruiting
Jackson, Tennessee, United States, 38305
Site Reference ID/Investigator# 53138 Recruiting
Memphis, Tennessee, United States, 38119
Principal Investigator: Site Reference ID/Investigator# 53138         
United States, Texas
Site Reference ID/Investigator# 50670 Recruiting
Dallas, Texas, United States, 75390-9032
Principal Investigator: Site Reference ID/Investigator# 50670         
Site Reference ID/Investigator# 89153 Recruiting
Denton, Texas, United States, 76210
Principal Investigator: Site Reference ID/Investigator# 89153         
Site Reference ID/Investigator# 74976 Recruiting
Desoto, Texas, United States, 75115
Principal Investigator: Site Reference ID/Investigator# 74976         
Site Reference ID/Investigator# 50701 Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Site Reference ID/Investigator# 50701         
Site Reference ID/Investigator# 74673 Recruiting
Frisco, Texas, United States, 75035
Principal Investigator: Site Reference ID/Investigator# 74673         
Site Reference ID/Investigator# 50700 Active, not recruiting
Houston, Texas, United States, 77054
Site Reference ID/Investigator# 50241 Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Site Reference ID/Investigator# 50241         
Site Reference ID/Investigator# 50699 Recruiting
Houston, Texas, United States, 77054
Principal Investigator: Site Reference ID/Investigator# 50699         
Site Reference ID/Investigator# 56606 Recruiting
Irving, Texas, United States, 75061
Principal Investigator: Site Reference ID/Investigator# 56606         
Site Reference ID/Investigator# 77657 Active, not recruiting
Longview, Texas, United States, 75605
Site Reference ID/Investigator# 65584 Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Site Reference ID/Investigator# 65584         
Site Reference ID/Investigator# 50223 Active, not recruiting
San Antonio, Texas, United States, 78229
Site Reference ID/Investigator# 50679 Recruiting
Schertz, Texas, United States, 78154
Principal Investigator: Site Reference ID/Investigator# 50679         
Site Reference ID/Investigator# 105875 Withdrawn
Tyler, Texas, United States, 75708
Site Reference ID/Investigator# 50986 Recruiting
Webster, Texas, United States, 77598
Principal Investigator: Site Reference ID/Investigator# 50986         
United States, Utah
Site Reference ID/Investigator# 50253 Active, not recruiting
Draper, Utah, United States, 84020
Site Reference ID/Investigator# 60142 Recruiting
Pleasant Grove, Utah, United States, 84062
Principal Investigator: Site Reference ID/Investigator# 60142         
Site Reference ID/Investigator# 78193 Recruiting
Riverton, Utah, United States, 84065
Principal Investigator: Site Reference ID/Investigator# 78193         
Site Reference ID/Investigator# 50712 Completed
Sandy, Utah, United States, 84094
United States, Virginia
Site Reference ID/Investigator# 50251 Withdrawn
Newport News, Virginia, United States, 23601
Site Reference ID/Investigator# 50234 Recruiting
Norfolk, Virginia, United States, 23502
Principal Investigator: Site Reference ID/Investigator# 50234         
Site Reference ID/Investigator# 50243 Recruiting
Richmond, Virginia, United States, 23225
Principal Investigator: Site Reference ID/Investigator# 50243         
Site Reference ID/Investigator# 52662 Recruiting
Richmond, Virginia, United States, 23235
Principal Investigator: Site Reference ID/Investigator# 52662         
United States, Washington
Site Reference ID/Investigator# 89635 Recruiting
Renton, Washington, United States, 98055
Principal Investigator: Site Reference ID/Investigator# 89635         
Site Reference ID/Investigator# 50228 Recruiting
Seattle, Washington, United States, 98105
Principal Investigator: Site Reference ID/Investigator# 50228         
Site Reference ID/Investigator# 54686 Active, not recruiting
Spokane, Washington, United States, 99207
United States, West Virginia
Site Reference ID/Investigator# 64266 Active, not recruiting
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Site Reference ID/Investigator# 50203 Active, not recruiting
LaCrosse, Wisconsin, United States, 54601
Site Reference ID/Investigator# 72896 Active, not recruiting
Middleton, Wisconsin, United States, 53562
Canada
Site Reference ID/Investigator# 66582 Withdrawn
Calgary, Canada, T2N 4L7
Site Reference ID/Investigator# 69582 Recruiting
Hamilton, Canada, L82 4K1
Principal Investigator: Site Reference ID/Investigator# 69582         
Site Reference ID/Investigator# 78473 Completed
London, Canada, N6A 5W9
Site Reference ID/Investigator# 70593 Active, not recruiting
Montreal, Canada, H4P 2S4
Site Reference ID/Investigator# 83053 Completed
Newmarket, Canada, L3Y 5G8
Site Reference ID/Investigator# 72893 Active, not recruiting
Ottawa, Canada, K1H 7W9
Site Reference ID/Investigator# 72894 Active, not recruiting
Sherbrooke, Canada, J1H 5N4
Site Reference ID/Investigator# 78633 Withdrawn
Windsor, Canada, N8X 3V6
Site Reference ID/Investigator# 69937 Recruiting
Winnipeg, Canada, R3A 1M3
Principal Investigator: Site Reference ID/Investigator# 69937         
Puerto Rico
Site Reference ID/Investigator# 65505 Completed
Ponce, Puerto Rico, 00716
Site Reference ID/Investigator# 65156 Recruiting
Rio Piedras, Puerto Rico, 00935
Principal Investigator: Site Reference ID/Investigator# 65156         
Site Reference ID/Investigator# 66587 Recruiting
San Juan, Puerto Rico, 00917
Principal Investigator: Site Reference ID/Investigator# 66587         
Site Reference ID/Investigator# 74973 Active, not recruiting
Santurce, Puerto Rico, 00909
Site Reference ID/Investigator# 64651 Recruiting
Santurce, Puerto Rico, 00909
Principal Investigator: Site Reference ID/Investigator# 64651         
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: April 9, 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 April 22, 2014