Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
1 other identifier
interventional
118
2 countries
54
Brief Summary
This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2019
Shorter than P25 for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 15, 2019
CompletedStudy Start
First participant enrolled
August 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2021
CompletedResults Posted
Study results publicly available
June 8, 2022
CompletedJune 8, 2022
May 1, 2022
1.5 years
May 6, 2019
May 16, 2022
May 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Menstrual Cycle Responders
A participant was considered a menstrual cycle responder if she has at least 2 normal menstrual cycles during the final 4 months of the treatment period. In addition, a participant was considered a complete menstrual cycle responder if she has normal menstrual cycles beginning at or before Month 3 that are maintained through Month 6 during the treatment period.
Week 0 (Baseline) to Week 24 (Month 6)
Secondary Outcomes (1)
Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1
Week 0 (Baseline), Week 1: before the morning dose (0 hour) and at 0.5 (± 5 minutes), 1 (± 5 minutes), 1.5 (± 5 minutes), 2 (± 15 minutes), 2.5 (± 15 minutes), 3 (± 15 minutes), 3.5 (± 15 minutes), and 4 (± 15 minutes) hours after dosing.
Study Arms (6)
Placebo
PLACEBO COMPARATORPlacebo taken orally twice a day (BID)
Elagolix 25 mg BID
EXPERIMENTALElagolix 25 mg taken orally BID plus placebo
Elagolix 50 mg Once Daily (QD)
EXPERIMENTALElagolix 50 mg taken orally QD plus placebo
Elagolix 75 mg BID
EXPERIMENTALElagolix 75 mg taken orally BID plus placebo
Elagolix 150 mg QD
EXPERIMENTALElagolix 150 mg taken orally QD plus placebo
Elagolix 300 mg QD
EXPERIMENTALElagolix 300 mg taken orally QD plus placebo
Interventions
Capsule administered orally
Capsule administered orally
Eligibility Criteria
You may qualify if:
- Participants with clinical diagnosis of PCOS.
- Participants with a body mass index (BMI) of 18.5 to 38 kg/m\^2 at time of Screening.
You may not qualify if:
- Participants with newly diagnosed medical condition requiring intervention that has not been stabilized at least 30 days prior to Baseline.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (54)
Alabama Clinical Therapeutics /ID# 211498
Birmingham, Alabama, 35235-3430, United States
Mobile, OBGYN P.C. /ID# 205574
Mobile, Alabama, 36608, United States
Medical Ctr for Clin Research /ID# 205694
San Diego, California, 92108, United States
UCSF Center for Reproductive Health /ID# 210836
San Francisco, California, 94158-2518, United States
Avail Clinical Research /ID# 210873
DeLand, Florida, 32720-0834, United States
University of FL Southside Women's Specialists /ID# 210872
Jacksonville, Florida, 32207-4918, United States
Segal Institute for Clinical Research /ID# 205490
North Miami, Florida, 33161-5821, United States
A Premier Medical Research of FL /ID# 215659
Orange City, Florida, 32763-2833, United States
Virtus Research Consultant,LLC /ID# 205475
Wellington, Florida, 33414, United States
Comprehensive Clinical Trials LLC /ID# 205458
West Palm Beach, Florida, 33409, United States
Mount Vernon Clinical Res, LLC /ID# 205695
Atlanta, Georgia, 30328, United States
Bingham Memorial Hospital /ID# 205606
Blackfoot, Idaho, 83221, United States
Leavitt Womens Healthcare /ID# 205571
Idaho Falls, Idaho, 83404-8322, United States
Womens Healthcare Assoc, DBA /ID# 211528
Idaho Falls, Idaho, 83404, United States
Sonora Clinical Research /ID# 205623
Meridian, Idaho, 83646-1144, United States
Asr, Llc /Id# 207037
Nampa, Idaho, 83687, United States
PRN Professional Research Network of Kansas, LLC /ID# 205875
Wichita, Kansas, 67205, United States
Clinical Trials Management, LLC - Covington /ID# 211219
Covington, Louisiana, 70433, United States
Clinical Trials Management, LLC - Metairie /ID# 205494
Metairie, Louisiana, 70006-4165, United States
Baltimore Suburban Health /ID# 205619
Baltimore, Maryland, 21208, United States
Johns Hopkins University /ID# 205617
Baltimore, Maryland, 21287, United States
Capital Women's Care - Frederi /ID# 210276
Frederick, Maryland, 21702, United States
NECCR Fall River LLC /ID# 205567
Fall River, Massachusetts, 02720-2972, United States
Wayne State University Physician Group - Southfield /ID# 210245
Southfield, Michigan, 48034, United States
Private practice: Dr. Rex G. Mabey JR /ID# 211149
Las Vegas, Nevada, 89128, United States
Dr. Nader and Associates M.D. P.C. /ID# 211150
North Las Vegas, Nevada, 89030-7187, United States
Cooper University Hospital/Sheridan Pavilion /ID# 205576
Marlton, New Jersey, 08053-3464, United States
University of New Mexico /ID# 212594
Albuquerque, New Mexico, 87102-4517, United States
SUNY Downstate Medical Center /ID# 211180
Brooklyn, New York, 11203, United States
University of Rochester - Strong Fertility Center - Rochester /ID# 210328
Rochester, New York, 14623-4284, United States
OB.GYN Associates of WNY /ID# 210765
West Seneca, New York, 14224, United States
Upstate Clinical Research Associates /ID# 205717
Williamsville, New York, 14221-6046, United States
Carolina Institute for Clinical Research - Fayetteville /ID# 211319
Fayetteville, North Carolina, 28303, United States
Wake Forest Baptist Medical Center /ID# 211473
Winston-Salem, North Carolina, 27157-0001, United States
Duplicate_Aventiv Research, Inc. /ID# 205460
Columbus, Ohio, 43213, United States
Univ Hosp Landerbrook /ID# 205558
Mayfield Heights, Ohio, 44124, United States
AC Clinical Research /ID# 205492
Tiffin, Ohio, 44883, United States
Penn State University and Milton S. Hershey Medical Center /ID# 205555
Hershey, Pennsylvania, 17033-2360, United States
Thomas Jefferson University /ID# 205614
Philadelphia, Pennsylvania, 19107, United States
Reading Hospital /ID# 211322
Reading, Pennsylvania, 19611, United States
Chattanooga Medical Research /ID# 215190
Chattanooga, Tennessee, 37404, United States
WR-Medical Research Center of Memphis LLC /ID# 205636
Memphis, Tennessee, 38120-8328, United States
The University of Texas Southwestern Medical Center /ID# 210804
Dallas, Texas, 75390-8575, United States
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 216266
Houston, Texas, 77024-2515, United States
Advances in Health, Inc. /ID# 211249
Houston, Texas, 77030, United States
Duplicate_Diagnostic Clinic of Longview /ID# 211019
Longview, Texas, 75605, United States
Center of Reproductive Medicine /ID# 211250
Webster, Texas, 77598, United States
Virginia Mason - Seattle Orthapedics /ID# 205586
Seattle, Washington, 98101, United States
Seattle Women's Health, Research, Gynecology /ID# 205569
Seattle, Washington, 98105, United States
North Spokane Women's Health /ID# 205585
Spokane, Washington, 99207, United States
Puerto Rico Medical Research /ID# 211104
Ponce, 00717, Puerto Rico
University of Puerto Rico, Medical Sciences Campus /ID# 212320
Rio Piedras, 00935, Puerto Rico
Duplicate_Rodriguez-Ginorio, San Juan /ID# 211105
San Juan, 00917, Puerto Rico
Mindful Medical Research /ID# 212323
San Juan, 00918-3756, Puerto Rico
Related Publications (1)
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.
PMID: 37398623DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 15, 2019
Study Start
August 12, 2019
Primary Completion
February 10, 2021
Study Completion
February 10, 2021
Last Updated
June 8, 2022
Results First Posted
June 8, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.