Clinical trial NCT03213457: A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
Official title: A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Keywords: Elagolix
Endometriosis associated pain
Dysmenorrhea (DYS)
Non-menstrual pelvic pain (NMPP)
ORILISSA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 681
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.


Eligibility criteria: Inclusion Criteria:

* Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening.
* Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization within 10 years prior to entry into Washout or Screening.
* Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.
* Participant must have the following documented in the e-Diary during the last 35 days prior to Study Day 1:

  1. At least 2 days of "moderate" or "severe" dysmenorrhea (DYS) AND either
  2. At least 2 days of "moderate" or "severe" non-menstrual pelvic pain (NMPP) and an average NMPP score of at least 1.0, OR
  3. At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at least 0.5.

Exclusion Criteria:

* Participant has chronic pelvic pain that is not caused by endometriosis, that requires chronic analgesic therapy, which would interfere with the assessment of endometriosis-related pain.
* Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled or intranasal corticosteroids are allowed.
* Participant has a history of any major depression or post-traumatic stress disorder (PTSD) within 2 years of the screening visit or other major psychiatric disorder at any time.
* Participant has a history of suicide attempts or answered "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the last 1 year at Screening or prior to randomization on Day 1.
* Participant has any history of osteoporosis or other metabolic bone disease or any condition that would interfere with obtaining adequate dual energy x-ray absorptiometry (DXA) measurements
* Screening DXA results of the lumbar spine (L1-L4), femoral neck or total hip bone mineral density (BMD) corresponding to less than 2.0 or more standard deviations below normal.
* Participant has either:

  1. a newly diagnosed, clinically significant medical condition that requires therapeutic intervention (e.g., new onset hypertension), that has not been stabilized 30 days prior to randomization on Day 1 OR
  2. a clinically significant medical condition that is anticipated to require intervention during the course of study participation (e.g., anticipated major elective surgery) OR
  3. an unstable medical condition that makes the subject an unsuitable candidate for the study in the opinion of the Investigator, (including, but not limited to, uncontrolled diabetes mellitus, uncontrolled hypertension, epilepsy requiring anti-epileptic medication, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).
* Participant has any conditions contraindicated with use of E2/NETA.

Primary outcomes:
measure: Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment
timeFrame: Month 6, Month 12
measure: Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment
timeFrame: Month 6, Month 12
Secondary outcomes:
measure: Change From Baseline in DYS at Month 12 Based on Daily Assessment
timeFrame: Baseline, Month 12
measure: Change From Baseline in DYS at Month 6 Based on Daily Assessment
timeFrame: Baseline, Month 6
measure: Change From Baseline in DYS at Month 3 Based on Daily Assessment
timeFrame: Baseline, Month 3
measure: Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment
timeFrame: Baseline, Month 12
measure: Change From Baseline in NMPP at Month 6 Based on Daily Assessment
timeFrame: Baseline, Month 6
measure: Change From Baseline in NMPP at Month 3 Based on Daily Assessment
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score
timeFrame: Baseline, Month 6
measure: Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment
timeFrame: Baseline, Month 12
measure: Change From Baseline in DYSP at Month 6 Based on Daily Assessment
timeFrame: Baseline, Month 6
measure: Change From Baseline in DYSP at Month 3 Based on Daily Assessment
timeFrame: Baseline, Month 3
measure: Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score
timeFrame: Baseline, Month 12
measure: Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS)
timeFrame: Baseline, Month 12
measure: Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS
timeFrame: Baseline, Month 6
measure: Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates /ID# 163087
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC /ID# 145503
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC /ID# 151468
state: Alabama
city: Fairhope
country: United States
facility: Southern Women's Specialists PC /ID# 148750
state: Alabama
city: Mobile
country: United States
facility: Women's Health Alliance of Mobile /ID# 150083
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama /ID# 148774
state: Alabama
city: Mobile
country: United States
facility: Mobile, Ob-Gyn, P.C. /ID# 145364
state: Alabama
city: Mesa
country: United States
facility: Mesa Obstetricians and Gynecologists /ID# 147320
state: Arizona
city: Tucson
country: United States
facility: Arizona Research Assoc /ID# 161703
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research /ID# 155600
state: Arizona
city: Searcy
country: United States
facility: Unity Health- Searcy Medical Center /ID# 203674
state: Arkansas
city: Cerritos
country: United States
facility: Core Healthcare Group /ID# 149321
state: California
city: Encino
country: United States
facility: HRC Fertility /ID# 154143
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Ctr /ID# 160530
state: California
city: Huntington Beach
country: United States
facility: HCP Clinical Research LLC /ID# 152045
state: California
city: Irvine
country: United States
facility: Alliance Research Centers /ID# 151240
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trial Serv /ID# 152428
state: California
city: Los Angeles
country: United States
facility: Olympia Clinical Trials /ID# 202325
state: California
city: Northridge
country: United States
facility: California Medical Research As /ID# 154746
state: California
city: Norwalk
country: United States
facility: Futura Research, Org /ID# 145406
state: California
city: Pasadena
country: United States
facility: Huntington Medical Foundation /ID# 154750
state: California
city: Sacramento
country: United States
facility: Northern California Research /ID# 159753
state: California
city: San Diego
country: United States
facility: Precision Research Institute - San Diego /ID# 152557
state: California
city: San Diego
country: United States
facility: MD Strategies Research Centers /ID# 152429
state: California
city: Simi Valley
country: United States
facility: Alta California Medical Group /ID# 155706
state: California
city: Denver
country: United States
facility: Downtown Womens Health Care /ID# 147955
state: Colorado
city: Greenwood Village
country: United States
facility: Advanced Women's Health Institute /ID# 145396
state: Colorado
city: Lakewood
country: United States
facility: Red Rocks OB/GYN /ID# 145325
state: Colorado
city: Thornton
country: United States
facility: The Women's Health Group - Thornton /ID# 203707
state: Colorado
city: Washington
country: United States
facility: James A. Simon, MD, PC /ID# 145480
state: District of Columbia
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC /ID# 147108
state: Florida
city: Brandon
country: United States
facility: Gulf Coast Research Group /ID# 162895
state: Florida
city: Clearwater
country: United States
facility: Olympian Clinical Research /ID# 148167
state: Florida
city: DeBary
country: United States
facility: Omega Research Maitland, LLC /ID# 145167
state: Florida
city: Fort Lauderdale
country: United States
facility: KO Clinical Research, LLC /ID# 145410
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates /ID# 145237
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Adv Rch /ID# 148768
state: Florida
city: Kissimmee
country: United States
facility: Vida Clinical Research /ID# 150282
state: Florida
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Center /ID# 148169
state: Florida
city: Miami Lakes
country: United States
facility: Precision Research Organization /ID# 145337
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc /ID# 145514
state: Florida
city: Miami
country: United States
facility: Genoma Research Group, Inc /ID# 152558
state: Florida
city: Miami
country: United States
facility: Vista Health Research LLC - Miami /ID# 151455
state: Florida
city: Miami
country: United States
facility: Palmetto Professional Research /ID# 153838
state: Florida
city: Miramar
country: United States
facility: Salom Tangir, LLC /ID# 148739
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research /ID# 145484
state: Florida
city: Saint Cloud
country: United States
facility: Oncova Clinical Research, Inc. /ID# 148175
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research - St Petersburg /ID# 145345
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clin. Res., LLC /ID# 145511
state: Florida
city: Stuart
country: United States
facility: Treasure Coast Research /ID# 148174
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 145424
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials /ID# 152554
state: Florida
city: Wellington
country: United States
facility: Virtus Research Consultants, LLC /ID# 147101
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials /ID# 145148
state: Florida
city: Alpharetta
country: United States
facility: Paramount Research Solutions /ID# 145226
state: Georgia
city: Alpharetta
country: United States
facility: Paramount Research Solutions /ID# 149320
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Research Trials /ID# 145494
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Women's Research Inst /ID# 145543
state: Georgia
city: College Park
country: United States
facility: Apogee Women's Health Inc. /ID# 145149
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Ins /ID# 159752
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC /ID# 148176
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gynecology Research Institute /ID# 149322
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime /ID# 161724
state: Idaho
city: Idaho Falls
country: United States
facility: Womens Healthcare Assoc, DBA /ID# 148744
state: Idaho
city: Meridian
country: United States
facility: Advanced Clinical Research /ID# 147086
state: Idaho
city: Meridian
country: United States
facility: Sonora Clinical Research /ID# 145541
state: Idaho
city: Nampa
country: United States
facility: Asr, Llc /Id# 161680
state: Idaho
city: Champaign
country: United States
facility: Women's Health Practice, LLC /ID# 145517
state: Illinois
city: Oak Brook
country: United States
facility: Affinity Clinical Research /ID# 151469
state: Illinois
city: Palos Heights
country: United States
facility: Center for Women's Research, Inc /ID# 145486
state: Illinois
city: Park Ridge
country: United States
facility: The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459
state: Illinois
city: Avon
country: United States
facility: American Health Network of Ind /ID# 167996
state: Indiana
city: Fort Wayne
country: United States
facility: Women's Health Advantage /ID# 145495
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic /ID# 145409
state: Iowa
city: Shawnee Mission
country: United States
facility: Womens & Family Care, LLC dba /ID# 145211
state: Kansas
city: Wichita
country: United States
facility: PRN Professional Research Network of Kansas, LLC /ID# 151463
state: Kansas
city: Wichita
country: United States
facility: Cypress Medical Research Ctr /ID# 147159
state: Kansas
city: Louisville
country: United States
facility: University of Louisville /ID# 154751
state: Kentucky
city: Louisville
country: United States
facility: Bluegrass Clinical Research /ID# 151209
state: Kentucky
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 145220
state: Louisiana
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 145520
state: Louisiana
city: Eunice
country: United States
facility: Horizon Research Group /ID# 148171
state: Louisiana
city: Marrero
country: United States
facility: Praetorian Pharmaceutical Res /ID# 145405
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Baptist OB/GYN Clinic /ID# 147144
state: Louisiana
city: New Orleans
country: United States
facility: Women Under Study, LLC /ID# 151216
state: Louisiana
city: Shreveport
country: United States
facility: Women's Health Clinic /ID# 155707
state: Louisiana
city: Shreveport
country: United States
facility: Omni Fertility and Laser Insti /ID# 145532
state: Louisiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center /ID# 161681
state: Maine
city: Baltimore
country: United States
facility: Univ Maryland School Medicine /ID# 151739
state: Maryland
city: Baltimore
country: United States
facility: Baltimore Suburban Health /ID# 147164
state: Maryland
city: Towson
country: United States
facility: Continental Clinical Solutions /ID# 152041
state: Maryland
city: Fall River
country: United States
facility: NECCR Fall River LLC /ID# 145329
state: Massachusetts
city: Fall River
country: United States
facility: Genesis Clinical Research - Fall River /ID# 148573
state: Massachusetts
city: Ann Arbor
country: United States
facility: ClinSite, LLC /ID# 145314
state: Michigan
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc. /ID# 145308
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Med Res Group /ID# 145527
state: Michigan
city: Southfield
country: United States
facility: Wayne State University Physician Group - Southfield /ID# 145431
state: Michigan
city: Saint Paul
country: United States
facility: Prism Research /ID# 159751
state: Minnesota
city: Lincoln
country: United States
facility: Womens Clinic of Lincoln, P.C. /ID# 145366
state: Nebraska
city: Las Vegas
country: United States
facility: Accent Clinical Trials /ID# 147109
state: Nevada
city: Las Vegas
country: United States
facility: Office of Edmond E. Pack, MD /ID# 148747
state: Nevada
city: Las Vegas
country: United States
facility: R. Garn Mabey Jr, MD Chartered /ID# 145361
state: Nevada
city: Neptune
country: United States
facility: Jersey Shore University Medical Center /ID# 148756
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson /ID# 152858
state: New Jersey
city: Totowa
country: United States
facility: St. Joseph's Regional Medical /ID# 157759
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc /ID# 154747
state: New Mexico
city: Albuquerque
country: United States
facility: Bosque Women's Care /ID# 147084
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center /ID# 148749
state: New York
city: Laurelton
country: United States
facility: Scott Research Inc. /ID# 161704
state: New York
city: New York
country: United States
facility: Manhattan Medical Research /ID# 145175
state: New York
city: New York
country: United States
facility: Columbia Univ Medical Center /ID# 145334
state: New York
city: Orchard Park
country: United States
facility: Hamburg Regional Gynecology Gr /ID# 161705
state: New York
city: West Seneca
country: United States
facility: OB.GYN Associates of WNY /ID# 161665
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte /ID# 145432
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC /ID# 154679
state: North Carolina
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center /ID# 145356
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research-Greensboro /ID# 155543
state: North Carolina
city: High Point
country: United States
facility: Pinewest Ob-Gyn, Inc. /ID# 151743
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's Centr /ID# 145386
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Resea /ID# 145353
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington /ID# 152555
state: North Carolina
city: Minot
country: United States
facility: Trinity Health Center Town /ID# 147102
state: North Dakota
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd /ID# 147107
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center /ID# 145428
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital /ID# 149244
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 145496
state: Ohio
city: Cleveland
country: United States
facility: Univ Hosp Cleveland /ID# 148741
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University /ID# 145444
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc. /ID# 145492
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research, Inc. /ID# 162896
state: Ohio
city: Fairborn
country: United States
facility: Wright State University & CTRA /ID# 145512
state: Ohio
city: Toledo
country: United States
facility: University of Toledo /ID# 145403
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University /ID# 155705
state: Oregon
city: Bryn Mawr
country: United States
facility: Main Line Fertility Center /ID# 150099
state: Pennsylvania
city: Erie
country: United States
facility: OB/GYN Associates of Erie /ID# 157935
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University and Milton S. Hershey Medical Center /ID# 145231
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 145470
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel Univ College of Med /ID# 149789
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research /ID# 162091
state: Pennsylvania
city: Columbia
country: United States
facility: Vista Clinical Research /ID# 148767
state: South Carolina
city: Greenville
country: United States
facility: University Medical Group /ID# 148777
state: South Carolina
city: Myrtle Beach
country: United States
facility: Venus Gynecology, LLC /ID# 145336
state: South Carolina
city: North Charleston
country: United States
facility: James T. Martin, Jr., MD., Obs /ID# 148755
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research /ID# 150992
state: South Carolina
city: Watertown
country: United States
facility: Brown Clinic, PLLP /ID# 154372
state: South Dakota
city: Bristol
country: United States
facility: Holston Medical Group /ID# 145449
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga Medical Research /ID# 145184
state: Tennessee
city: Chattanooga
country: United States
facility: WR-ClinSearch /ID# 145205
state: Tennessee
city: Jackson
country: United States
facility: The Jackson Clinic, PA /ID# 145303
state: Tennessee
city: Memphis
country: United States
facility: Research Memphis Associates, LLC /ID# 150100
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc. /ID# 145224
state: Tennessee
city: Austin
country: United States
facility: Lotus Gynecology /ID# 148479
state: Texas
city: Austin
country: United States
facility: AA (Austin Area) ObGyn PLLC /ID# 205696
state: Texas
city: Austin
country: United States
facility: Sirius Clinical Research, LLC /ID# 154749
state: Texas
city: Beaumont
country: United States
facility: Gadolin Research, LLC /ID# 201383
state: Texas
city: Bedford
country: United States
facility: Center for Assisted Reprod. /ID# 154748
state: Texas
city: Dallas
country: United States
facility: Texas Health Presbyterian Hosp /ID# 150098
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center /ID# 145201
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott & White /ID# 170430
state: Texas
city: Fort Worth
country: United States
facility: Signature Gyn Services /ID# 145534
state: Texas
city: Frisco
country: United States
facility: Willowbend Health and Wellness - Frisco /ID# 145245
state: Texas
city: Houston
country: United States
facility: Next Innovative Clinical Research /ID# 203863
state: Texas
city: Houston
country: United States
facility: Advances in Health, Inc. /ID# 145425
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital /ID# 170586
state: Texas
city: Houston
country: United States
facility: Precision Research Institute - Houston /ID# 154370
state: Texas
city: Houston
country: United States
facility: The Woman's Hospital of Texas /ID# 145316
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc /ID# 148776
state: Texas
city: Lampasas
country: United States
facility: FMC Science /ID# 150981
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc /ID# 147100
state: Texas
city: San Antonio
country: United States
facility: VIP Trials /ID# 151745
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials-San Antonio /ID# 145363
state: Texas
city: Sugar Land
country: United States
facility: Houston Ctr for Clin Research /ID# 148799
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicin /ID# 145467
state: Texas
city: Draper
country: United States
facility: Corner Canyon Obstetrics and G /ID# 145519
state: Utah
city: Layton
country: United States
facility: Tanner Clinic /ID# 148786
state: Utah
city: Pleasant Grove
country: United States
facility: Revere Health /ID# 145540
state: Utah
city: Franklin
country: United States
facility: Southampton Women's Health /ID# 151691
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477
state: Virginia
city: North Chesterfield
country: United States
facility: Clinical Research Partners, LL /ID# 145392
state: Virginia
city: North Chesterfield
country: United States
facility: Clinical Research Partners, LL /ID# 145416
state: Virginia
city: Richmond
country: United States
facility: Clinical Trials Virginia, Inc. /ID# 145430
state: Virginia
city: Richmond
country: United States
facility: Alliance Womens Health /ID# 148770
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Clinical Research /ID# 145397
state: Virginia
city: Puyallup
country: United States
facility: Clinical Research Adv, Inc. /ID# 149257
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center /ID# 145387
state: Washington
city: Seattle
country: United States
facility: Seattle Women's Health, Research, Gynecology /ID# 145341
state: Washington
city: Spokane
country: United States
facility: North Spokane Women's Health /ID# 145382
state: Washington
city: Tacoma
country: United States
facility: Madigan Army Medical Center /ID# 145186
state: Washington
city: St. John's
country: Canada
facility: Strand Clinic /ID# 152582
state: Newfoundland and Labrador
city: Ottawa
country: Canada
facility: The Ottawa Hospital /ID# 148927
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc /ID# 151453
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hosp.-Toronto /ID# 148972
state: Ontario
city: Windsor
country: Canada
facility: Victory Reproductive Care /ID# 149016
state: Ontario
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Research /ID# 152040
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico /ID# 149018
city: San Juan
country: Puerto Rico
facility: Rodriguez-Ginorio, San Juan /ID# 145545
city: San Juan
country: Puerto Rico
facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 145546
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Watts NB, Binkley N, Owens CD, Al-Hendy A, Puscheck EE, Shebley M, Schlaff WD, Simon JA. Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life. J Womens Health (Larchmt). 2021 Oct;30(10):1416-1430. doi: 10.1089/jwh.2020.8989. Epub 2021 Aug 25.