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

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