Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
NCT ID: NCT03951077
Last Updated: 2022-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
118 participants
INTERVENTIONAL
2019-08-12
2021-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo taken orally twice a day (BID)
Placebo
Capsule administered orally
Elagolix 25 mg BID
Elagolix 25 mg taken orally BID plus placebo
Elagolix
Capsule administered orally
Placebo
Capsule administered orally
Elagolix 50 mg Once Daily (QD)
Elagolix 50 mg taken orally QD plus placebo
Elagolix
Capsule administered orally
Placebo
Capsule administered orally
Elagolix 75 mg BID
Elagolix 75 mg taken orally BID plus placebo
Elagolix
Capsule administered orally
Placebo
Capsule administered orally
Elagolix 150 mg QD
Elagolix 150 mg taken orally QD plus placebo
Elagolix
Capsule administered orally
Placebo
Capsule administered orally
Elagolix 300 mg QD
Elagolix 300 mg taken orally QD plus placebo
Elagolix
Capsule administered orally
Placebo
Capsule administered orally
Interventions
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Elagolix
Capsule administered orally
Placebo
Capsule administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with a body mass index (BMI) of 18.5 to 38 kg/m\^2 at time of Screening.
Exclusion Criteria
* Participants with a significant medical condition that require intervention during the course of study participation (such as anticipated major elective surgery).
* Participants with an unstable medical condition (including, but not limited to, uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).
18 Years
35 Years
FEMALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Alabama Clinical Therapeutics /ID# 211498
Birmingham, Alabama, United States
Mobile, OBGYN P.C. /ID# 205574
Mobile, Alabama, United States
Medical Ctr for Clin Research /ID# 205694
San Diego, California, United States
UCSF Center for Reproductive Health /ID# 210836
San Francisco, California, United States
Avail Clinical Research /ID# 210873
DeLand, Florida, United States
University of FL Southside Women's Specialists /ID# 210872
Jacksonville, Florida, United States
Segal Institute for Clinical Research /ID# 205490
North Miami, Florida, United States
A Premier Medical Research of FL /ID# 215659
Orange City, Florida, United States
Virtus Research Consultant,LLC /ID# 205475
Wellington, Florida, United States
Comprehensive Clinical Trials LLC /ID# 205458
West Palm Beach, Florida, United States
Mount Vernon Clinical Res, LLC /ID# 205695
Atlanta, Georgia, United States
Bingham Memorial Hospital /ID# 205606
Blackfoot, Idaho, United States
Leavitt Womens Healthcare /ID# 205571
Idaho Falls, Idaho, United States
Womens Healthcare Assoc, DBA /ID# 211528
Idaho Falls, Idaho, United States
Sonora Clinical Research /ID# 205623
Meridian, Idaho, United States
Asr, Llc /Id# 207037
Nampa, Idaho, United States
PRN Professional Research Network of Kansas, LLC /ID# 205875
Wichita, Kansas, United States
Clinical Trials Management, LLC - Covington /ID# 211219
Covington, Louisiana, United States
Clinical Trials Management, LLC - Metairie /ID# 205494
Metairie, Louisiana, United States
Baltimore Suburban Health /ID# 205619
Baltimore, Maryland, United States
Johns Hopkins University /ID# 205617
Baltimore, Maryland, United States
Capital Women's Care - Frederi /ID# 210276
Frederick, Maryland, United States
NECCR Fall River LLC /ID# 205567
Fall River, Massachusetts, United States
Wayne State University Physician Group - Southfield /ID# 210245
Southfield, Michigan, United States
Private practice: Dr. Rex G. Mabey JR /ID# 211149
Las Vegas, Nevada, United States
Dr. Nader and Associates M.D. P.C. /ID# 211150
North Las Vegas, Nevada, United States
Cooper University Hospital/Sheridan Pavilion /ID# 205576
Marlton, New Jersey, United States
University of New Mexico /ID# 212594
Albuquerque, New Mexico, United States
SUNY Downstate Medical Center /ID# 211180
Brooklyn, New York, United States
University of Rochester - Strong Fertility Center - Rochester /ID# 210328
Rochester, New York, United States
OB.GYN Associates of WNY /ID# 210765
West Seneca, New York, United States
Upstate Clinical Research Associates /ID# 205717
Williamsville, New York, United States
Carolina Institute for Clinical Research - Fayetteville /ID# 211319
Fayetteville, North Carolina, United States
Wake Forest Baptist Medical Center /ID# 211473
Winston-Salem, North Carolina, United States
Duplicate_Aventiv Research, Inc. /ID# 205460
Columbus, Ohio, United States
Univ Hosp Landerbrook /ID# 205558
Mayfield Heights, Ohio, United States
AC Clinical Research /ID# 205492
Tiffin, Ohio, United States
Penn State University and Milton S. Hershey Medical Center /ID# 205555
Hershey, Pennsylvania, United States
Thomas Jefferson University /ID# 205614
Philadelphia, Pennsylvania, United States
Reading Hospital /ID# 211322
Reading, Pennsylvania, United States
Chattanooga Medical Research /ID# 215190
Chattanooga, Tennessee, United States
WR-Medical Research Center of Memphis LLC /ID# 205636
Memphis, Tennessee, United States
The University of Texas Southwestern Medical Center /ID# 210804
Dallas, Texas, United States
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 216266
Houston, Texas, United States
Advances in Health, Inc. /ID# 211249
Houston, Texas, United States
Duplicate_Diagnostic Clinic of Longview /ID# 211019
Longview, Texas, United States
Center of Reproductive Medicine /ID# 211250
Webster, Texas, United States
Virginia Mason - Seattle Orthapedics /ID# 205586
Seattle, Washington, United States
Seattle Women's Health, Research, Gynecology /ID# 205569
Seattle, Washington, United States
North Spokane Women's Health /ID# 205585
Spokane, Washington, United States
Puerto Rico Medical Research /ID# 211104
Ponce, , Puerto Rico
University of Puerto Rico, Medical Sciences Campus /ID# 212320
Rio Piedras, , Puerto Rico
Duplicate_Rodriguez-Ginorio, San Juan /ID# 211105
San Juan, , Puerto Rico
Mindful Medical Research /ID# 212323
San Juan, , Puerto Rico
Countries
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References
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Snabes MC, Ng J, Li H, Ali I, Shebley M, Schlaff WD. Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome. F S Rep. 2023 Feb 21;4(2):206-212. doi: 10.1016/j.xfre.2023.02.007. eCollection 2023 Jun.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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M16-837
Identifier Type: -
Identifier Source: org_study_id
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