This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01620528
First received: May 15, 2012
Last updated: March 18, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Proportion of responders based on daily assessment of dysmenorrhea (DYS) [ Time Frame: At Month 3 of the Treatment Period ]
    via eDiary

  • Proportion of responders based on daily assessment of non-menstrual pelvic pain (NMPP) [ Time Frame: At Month 3 of Treatment Period ]
    via eDiary


Secondary Outcome Measures:
  • Change from baseline to each month in numeric rating scale (NRS) scores [ Time Frame: From baseline (prior to study drug administration) to Month 3 of the Treatment Period ]
    via eDiary

  • Change from baseline to each month in dysmenorrhea (DYS) [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each month in non-menstrual pelvic pain (NMPP) [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline in analgesic use across both classes of rescue analgesics based on pill counts [ Time Frame: Change from baseline (prior to study drug administration) to Month 3 and Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each month in dyspareunia [ Time Frame: From baseline (prior to study drug administration) to Month 3 of Treatment Period ]
    via eDiary

  • Change from baseline in use of narcotic class of medication based on pill counts [ Time Frame: From baseline (prior to study drug administration) to Month 3 of Treatment Period ]
    via eDiary

  • Proportion of responders for each month, except Month 3, in DYS [ Time Frame: Up to Month 6 of Treatment Period ]
    via eDiary

  • Proportion of responders for each month, except Month 3, in NMPP [ Time Frame: Up to Month 6 of Treatment Period ]
    via eDiary

  • Proportion of responders at each month for dyspareunia [ Time Frame: Up to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each month, except Month 6, in the mean pain score for DYS [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each month, except Month 6, in the mean pain score for NMPP [ Time Frame: From baseline (prior to study drug administration) to Month 6 ]
    via eDiary

  • Change from baseline to each month, except Month 3, in the mean pain score of dyspareunia [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each month, except Months 3 and 6, in analgesic use across both classes of rescue analgesics to treat endometriosis-related pain [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Response at each month to Patient Global Impression of Change (PGIC) [ Time Frame: Up to Month 6 of Treatment Period ]
    PGIC questionnaire

  • Change from baseline to each month, except Month 3, in NRS scores [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Change from baseline to each scheduled assessment in the scores in the pain domain of the Endometriosis Health Profile-30 (EHP-30) [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    EHP-30 questionnaire

  • Change from baseline to each scheduled assessment in the scores in the sexual relationship domain of the Endometriosis Health Profile-30 (EHP-30) [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    EHP-30 questionnaire

  • Change from baseline to each scheduled assessment in Health Related Productivity Questionnaire (HRPQ) scores [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    HRPQ

  • Number of endometriosis-related non-study health visits [ Time Frame: Up to Month 6 of Treatment Period ]
    HRPQ

  • Number of days in hospital [ Time Frame: Up to Month 6 of Treatment Period ]
    HRPQ

  • Type of procedures performed [ Time Frame: Up to Month 6 of Treatment Period ]
    HRPQ

  • Percent change from baseline to each month in the mean pain score for DYS [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary

  • Percent change from baseline to each month in the mean pain score for NMPP [ Time Frame: From baseline (prior to study drug administration) to Month 6 of Treatment Period ]
    via eDiary


Enrollment: 872
Study Start Date: May 2012
Study Completion Date: September 2015
Primary Completion Date: November 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   (Adult)
Sexes 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
Alabama Clinical Therapeutics, LLC /ID# 51487
Birmingham, Alabama, United States, 35235
Cullman Clinical Research /ID# 87953
Cullman, Alabama, United States, 35058
Mobile, Ob-Gyn, P.C. /ID# 64270
Mobile, Alabama, United States, 36608
United States, Arizona
New Horizon's Women's Care /ID# 50717
Chandler, Arizona, United States, 85224
Radiant Research, Inc. /ID# 53029
Chandler, Arizona, United States, 85224
Dedicated Clinical Research, Inc. /ID# 89634
Goodyear, Arizona, United States, 85395
Womens Health Research /ID# 50222
Phoenix, Arizona, United States, 85015
Arizona Research Center, Inc. /ID# 63980
Phoenix, Arizona, United States, 85023
Desert Sun Clinical Research, LLC /ID# 75493
Tucson, Arizona, United States, 85710
Visions Clinical Research Tucson /ID# 50261
Tucson, Arizona, United States, 85712
United States, Arkansas
Arkansas Primary Care Clinics, PA /ID# 82573
Little Rock, Arkansas, United States, 72204
The Woman's Clinic, P.A. /ID# 50688
Little Rock, Arkansas, United States, 72205
United States, California
Advanced RX Clinical Research /ID# 102895
Artesia, California, United States, 90701
Yassear Clinical Research /ID# 53034
Carmichael, California, United States, 95608
Reliance Institute of Clinical Research /ID# 96747
Chino, California, United States, 91710
Dr. Thomas Hughes, Davis, CA /ID# 73673
Davis, California, United States, 95616
Women's Clinical Research /ID# 50669
Encinitas, California, United States, 92024
UC San Diego Movement Disorder Center /ID# 56602
La Jolla, California, United States, 92093-0633
Axis Clinical Trials /ID# 74793
Los Angeles, California, United States, 90036
Healthcare Partners Medical Group /ID# 69583
Redondo Beach, California, United States, 90277
Sharp Rees-Stealy Medical Group, Inc. /ID# 50715
San Diego, California, United States, 92101
University Clinical Research /ID# 50247
San Diego, California, United States, 92103
Medical Center for Clinical Research /ID# 50227
San Diego, California, United States, 92108
Diablo Clinical Research, Inc. /ID# 79813
Walnut Creek, California, United States, 94598
United States, Colorado
Clinical Research Advantage, Inc. /ID# 65748
Colorado Springs, Colorado, United States, 80906
Comprehensive Womens Care of Colorado Springs, LLC /ID# 50220
Colorado Springs, Colorado, United States, 80910
Downtown Womens Health Care, Denver /ID# 50254
Denver, Colorado, United States, 80209
Advanced Women's Health /ID# 53824
Denver, Colorado, United States, 80246
Red Rocks OB/GYN /ID# 50263
Lakewood, Colorado, United States, 80228
Colorado Center for Reproductive Medicine /ID# 64623
Lonetree, Colorado, United States, 80124
United States, Connecticut
Danbury Clinical Research, LLC /ID# 74974
Danbury, Connecticut, United States, 06810
Thameside Ob/Gyn Centre /ID# 53822
Groton, Connecticut, United States, 06340
SHE Medical Associates /ID# 53130
Hartford, Connecticut, United States, 06105
Yale Univ School of Medicine /ID# 71916
New Haven, Connecticut, United States, 06510-8063
Coastal Connecticut Research, LLC /ID# 50709
New London, Connecticut, United States, 06320
University of Connecticut Health Center /ID# 50230
Southington, Connecticut, United States, 06489
United States, Florida
Visions Clinical Research /ID# 50205
Boynton Beach, Florida, United States, 33472
Florida Clinical Research Group, LLC /ID# 74978
Clearwater, Florida, United States, 33759
Clinical Research of West Florida, Inc. /ID# 58063
Clearwater, Florida, United States, 33765
Omega Research Consultants, LLC /ID# 59941
Debary, Florida, United States, 32713
KO Clinical Research, LLC /ID# 61830
Fort Lauderdale, Florida, United States, 33316
Nova Southeastern University /ID# 64268
Fort Lauderdale, Florida, United States, 33328
Clinical Physiology Associates /ID# 96746
Fort Myers, Florida, United States, 33916
Southeastern Integrated Medical, PL, d/b/a /ID# 74977
Gainesville, Florida, United States, 32607
Direct Helpers Medical Center, Inc. /ID# 118415
Hialeah, Florida, United States, 33012
VERITAS Research Corp. /ID# 102575
Miami Lakes, Florida, United States, 33014
LCC Medical Research Institute, LLC /ID# 89953
Miami, Florida, United States, 33126
Suncoast Clinical Research, Inc. /ID# 50248
New Port Richey, Florida, United States, 34652
Suncoast Clinical Research, Inc. /ID# 57845
New Port Richey, Florida, United States, 34652
Healthcare Clinical Data, Inc. /ID# 50687
North Miami, Florida, United States, 33161
All Womens Healthcare of West Broward /ID# 69584
Plantation, Florida, United States, 33324
Physician Care Clinical Research, LLC /ID# 53826
Sarasota, Florida, United States, 34239
University of South Florida /ID# 50240
Tampa, Florida, United States, 33606
Comprehensive Clinical Trials, LLC /ID# 51492
West Palm Beach, Florida, United States, 33409
United States, Georgia
Masters of Clinical Research, Inc. /ID# 56605
Augusta, Georgia, United States, 30909
Southeast Regional Research Group /ID# 69422
Augusta, Georgia, United States, 30909
Mount Vernon Clinical Research, LLC /ID# 50209
Sandy Springs, Georgia, United States, 30328
Fellows Research Alliance /ID# 82575
Savannah, Georgia, United States, 31406
United States, Idaho
The Women's Clinic /ID# 54685
Boise, Idaho, United States, 83712
Womens Healthcare Associates P.A, DBA /ID# 50258
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Center for Womens Research /ID# 50249
Chicago, Illinois, United States, 60612
Chicago Clinical Research Institute /ID# 78634
Chicago, Illinois, United States, 60616
Institute for the Study and Treatment of Endometriosis /ID# 50216
Oak Brook, Illinois, United States, 60523
United States, Indiana
American Health Network of IN LLC /ID# 80754
Avon, Indiana, United States, 46123
The South Bend Clinic Granger /ID# 58062
Granger, Indiana, United States, 46530
United States, Iowa
The Iowa Clinic /ID# 69934
West Des Moines, Iowa, United States, 50266
United States, Kansas
GTC Research /ID# 81733
Shawnee, Kansas, United States, 66218
United States, Kentucky
Central Kentucky Research Associates, Inc. /ID# 81734
Lexington, Kentucky, United States, 40509
Research Integrity, LLC /ID# 93573
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Praetorian Pharmaceutical Research, LLC /ID# 53032
Marrero, Louisiana, United States, 70072
Tulane University /ID# 89315
New Orleans, Louisiana, United States, 70112
Women Under Study /ID# 50714
New Orleans, Louisiana, United States, 70115
United States, Maryland
Frederick OB/GYN /ID# 59063
Frederick, Maryland, United States, 21702
United States, Massachusetts
Neurocare Center for Research /ID# 62226
Brookline, Massachusetts, United States, 02446
UMass Memorial Medical Center /ID# 74715
Worcester, Massachusetts, United States, 01605
United States, Michigan
ClinSite, LLC /ID# 50262
Ann Arbor, Michigan, United States, 48106
Great Lakes Research Group, Inc. /ID# 63149
Bay City, Michigan, United States, 48706
Wayne State University /ID# 50671
Detroit, Michigan, United States, 48201
Grand Rapids Women's Health /ID# 50207
Grand Rapids, Michigan, United States, 49503
Saginaw Valley Medical Research Group, LLC /ID# 50718
Saginaw, Michigan, United States, 48604
United States, Minnesota
Ridgeview Research /ID# 50696
Chaska, Minnesota, United States, 55318
United States, Missouri
Washington University School of Medicine /ID# 73793
St. Louis, Missouri, United States, 63110
United States, Montana
Billings Clinic Research Center /ID# 50678
Billings, Montana, United States, 59101
Montana Medical Research, Inc. /ID# 50260
Missoula, Montana, United States, 59808
United States, Nebraska
Womens Clinic of Lincoln, P.C. /ID# 50264
Lincoln, Nebraska, United States, 68510
CHI Health /ID# 65902
Omaha, Nebraska, United States, 68124
United States, Nevada
Office of Annette F. Mayes, MD /ID# 75497
Las Vegas, Nevada, United States, 89106
Office of Edmond E. Pack, MD /ID# 70594
Las Vegas, Nevada, United States, 89113
Dr. R. Garn Mabey, Las Vegas, NV /ID# 50984
Las Vegas, Nevada, United States, 89128
Reno Clinical Trials, LLC /ID# 53028
Sparks, Nevada, United States, 89434
United States, New Jersey
CarePoint Health Research Institute /ID# 97396
Jersey City, New Jersey, United States, 07306
Lawrence OB/GYN Clinical Research, LLC /ID# 64272
Lawrence, New Jersey, United States, 08648
Women's Health Research Center /ID# 50218
Plainsboro, New Jersey, United States, 08536
United States, New Mexico
Albuquerque Clinical Trials /ID# 65743
Albuquerque, New Mexico, United States, 87102
Southwest Clinical Research /ID# 53762
Albuquerque, New Mexico, United States, 87109
United States, New York
Montefiore Medical Center, Moses Division /ID# 72895
Bronx, New York, United States, 10467
SUNY Downstate Medical Center, Univ Hosp Brooklyn /ID# 59062
Brooklyn, New York, United States, 11203
New York Center for Women's Health Research, P.C. /ID# 80753
New York, New York, United States, 10038
Suffolk Obstetrics and Gynecology, LLP /ID# 57838
Port Jefferson, New York, United States, 11777
Richmond OB/GYN Associates PC /ID# 77473
Staten Island, New York, United States, 10306
United States, North Carolina
PMG Research of Charlotte, LLC /ID# 65983
Charlotte, North Carolina, United States, 28209
Carolina Women's Research and Wellness Center /ID# 60483
Durham, North Carolina, United States, 27713
Hawthorne Medical Research, Inc /ID# 69935
Greensboro, North Carolina, United States, 27408
Eastern Carolina Women's Center /ID# 50705
New Bern, North Carolina, United States, 28562
Wake Research Associates, LLC /ID# 50666
Raleigh, North Carolina, United States, 27612
Carolina Medical Trials /ID# 53031
Winston-Salem, North Carolina, United States, 27103
Hawthorne Medical Research, Inc /ID# 50224
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Mid Dakota Clinic /ID# 50674
Bismarck, North Dakota, United States, 58501
Trinity Health Medical Arts Clinic /ID# 78474
Minot, North Dakota, United States, 58701
United States, Ohio
Radiant Research Inc. /ID# 53135
Akron, Ohio, United States, 44311
Day Star Clinical Research, Inc /ID# 53027
Akron, Ohio, United States, 44313
Katz and Kade, Inc /ID# 69585
Cincinnati, Ohio, United States, 45219
University of Cincinnati Physicians /ID# 83013
Cincinnati, Ohio, United States, 45267-0457
Radiant Research, Inc /ID# 53025
Columbus, Ohio, United States, 43212
Womens Health Research /ID# 50242
Columbus, Ohio, United States, 43213
Complete Healthcare for Women /ID# 66584
Columbus, Ohio, United States, 43231
University Hospitals Landerbrook Health Center /ID# 60863
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
Oklahoma Arthritis Center /ID# 50257
Edmond, Oklahoma, United States, 73013
United States, Oregon
Dr. Richard A. Beyerlein, Eugene, OR /ID# 50208
Eugene, Oregon, United States, 97401
Advanced Clinical Research, Medford /ID# 50252
Medford, Oregon, United States, 97504
Sunstone Medical Research, LLC /ID# 56704
Medford, Oregon, United States, 97504
Columbia Research Group, Inc /ID# 50706
Portland, Oregon, United States, 97239
Oregon Health & Science University (OHSU) /ID# 56702
Portland, Oregon, United States, 97239
United States, Pennsylvania
The Clinical Trial Center, LLC /ID# 50684
Jenkintown, Pennsylvania, United States, 19046
Drexel University College of Medicine /ID# 50259
Philadelphia, Pennsylvania, United States, 19102
University of Pennsylvania /ID# 59082
Philadelphia, Pennsylvania, United States, 19104
Clinical Trials Research Services, LLC /ID# 77658
Pittsburgh, Pennsylvania, United States, 15206
PEAK Research, LLC /ID# 55105
Upper St. Clair, Pennsylvania, United States, 15241
Advanced Clinical Concepts /ID# 53023
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Fellows Research Alliance /ID# 82574
Bluffton, South Carolina, United States, 29910
SC Clinical Research Center, LLC /ID# 71717
Columbia, South Carolina, United States, 29201
Greenville Health System Cancer Institute /ID# 64622
Greenville, South Carolina, United States, 29605
Greenville Pharmaceutical Research /ID# 50221
Greenville, South Carolina, United States, 29615
Magnolia Ob/Gyn Research Center /ID# 50983
Myrtle Beach, South Carolina, United States, 29572
Dr. James T Martin, Jr., North Charleston, SC /ID# 75496
North Charleston, South Carolina, United States, 29406
United States, Tennessee
Holston Medical Group (Seasons of Bristol) /ID# 50245
Bristol, Tennessee, United States, 37620
Chattanooga GYN Oncology LLC /ID# 53022
Chattanooga, Tennessee, United States, 37403
Chattanooga Medical Research, LLC /ID# 64275
Chattanooga, Tennessee, United States, 37404
The Jackson Clinic, PA /ID# 50673
Jackson, Tennessee, United States, 38305
Memphis Research Associates, LLC /ID# 53138
Memphis, Tennessee, United States, 38119
United States, Texas
UT Southwestern Medical Center /ID# 50670
Dallas, Texas, United States, 75390-9032
The Women's Centre /ID# 89153
Denton, Texas, United States, 76210
Dr. Thomas Lane Dykes, Desoto, TX /ID# 74976
Desoto, Texas, United States, 75115
Texas Health Care, PLLC /ID# 50701
Fort Worth, Texas, United States, 76104
Willowbend Health and Wellness Associates /ID# 74673
Frisco, Texas, United States, 75035
Advances in Health, Inc. /ID# 50241
Houston, Texas, United States, 77030
The Woman's Hospital of Texas Clinical Research Center /ID# 50699
Houston, Texas, United States, 77054
TMC Life Research, Inc /ID# 50700
Houston, Texas, United States, 77054
Brown Stone Clinical Trials, LLC /ID# 56606
Irving, Texas, United States, 75061
DCOL Center for Clinical Research /ID# 77657
Longview, Texas, United States, 75605
Clinical Trials of Texas, Inc. /ID# 50223
San Antonio, Texas, United States, 78229
Clinical Trials of Texas, Inc. /ID# 65584
San Antonio, Texas, United States, 78229
Northeast Clinical Research of San Antonio /ID# 50679
Schertz, Texas, United States, 78154
Center of Reproductive Medicine /ID# 50986
Webster, Texas, United States, 77598
United States, Utah
Corner Canyon Obstetrics and Gynecology /ID# 50253
Draper, Utah, United States, 84020
Central Utah Clinic /ID# 60142
Pleasant Grove, Utah, United States, 84062
Granger Medical Clinic-Riverton /ID# 78193
Riverton, Utah, United States, 84065
Alta View Women's Center PC /ID# 50712
Sandy, Utah, United States, 84094
United States, Virginia
Tidewater Physicians for Women /ID# 50234
Norfolk, Virginia, United States, 23502
Clinical Trials of Virginia, Inc. /ID# 50243
Richmond, Virginia, United States, 23225
Virginia Commonwealth University /ID# 52662
Richmond, Virginia, United States, 23235
United States, Washington
Valley Women's Clinic /ID# 89635
Renton, Washington, United States, 98055
Seattle Women's Health, Research, Gynecology /ID# 50228
Seattle, Washington, United States, 98105
North Spokane Women's Health /ID# 54686
Spokane, Washington, United States, 99207
United States, West Virginia
Charleston Area Medical Ctr, Health Education and Research /ID# 64266
Charleston, West Virginia, United States, 25304
United States, Wisconsin
University of Wisconsin LaCrosse /ID# 50203
LaCrosse, Wisconsin, United States, 54601
UW Health Generations Fertility Care /ID# 72896
Middleton, Wisconsin, United States, 53562
Canada
Hamilton Health Sciences /ID# 69582
Hamilton, Canada, L8S 4K1
Victoria Hospital /ID# 78473
London, Canada, N6A 5W9
Clinique OVO /ID# 70593
Montreal, Canada, H4P 2S4
SKDS Research Inc. /ID# 83053
Newmarket, Canada, L3Y 5G8
The Ottawa Hospital /ID# 72893
Ottawa, Canada, K1H 7W9
Crc-Chus /Id# 72894
Sherbrooke, Canada, J1H 5N4
Manitoba Clinic /ID# 69937
Winnipeg, Canada, R3A 1M3
Puerto Rico
Ponce School of Medicine /ID# 65505
Ponce, Puerto Rico, 00716
University of Puerto Rico, School of Medicine /ID# 65156
Rio Piedras, Puerto Rico, 00935
Dr. Henry Rodriguez Ginorio, San Juan, PR /ID# 66587
San Juan, Puerto Rico, 00917
Gynecology Reproductive Endocrinology and Fertility Inst /ID# 64651
Santurce, Puerto Rico, 00909
Maternal Fetal Medicine and Gynecology Center /ID# 74973
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Rachel Duan, MD AbbVie
  More Information

Responsible Party: 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: March 18, 2017

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 23, 2017