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Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Elagolix
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Hormone, Elagolix

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • Alabama Clinical Therapeutics /ID# 211498
  • Mobile, OBGYN P.C. /ID# 205574
  • Medical Ctr for Clin Research /ID# 205694
  • UCSF Center for Reproductive Health /ID# 210836
  • Avail Clinical Research /ID# 210873
  • University of FL Southside Women's Specialists /ID# 210872
  • Segal Institute for Clinical Research /ID# 205490
  • A Premier Medical Research of FL /ID# 215659
  • Virtus Research Consultant,LLC /ID# 205475
  • Comprehensive Clinical Trials LLC /ID# 205458
  • Mount Vernon Clinical Res, LLC /ID# 205695
  • Bingham Memorial Hospital /ID# 205606
  • Leavitt Womens Healthcare /ID# 205571
  • Womens Healthcare Assoc, DBA /ID# 211528
  • Sonora Clinical Research /ID# 205623
  • Asr, Llc /Id# 207037
  • PRN Professional Research Network of Kansas, LLC /ID# 205875
  • Clinical Trials Management, LLC - Covington /ID# 211219
  • Clinical Trials Management, LLC - Metairie /ID# 205494
  • Baltimore Suburban Health /ID# 205619
  • Johns Hopkins University /ID# 205617
  • Capital Women's Care - Frederi /ID# 210276
  • NECCR Fall River LLC /ID# 205567
  • Wayne State University Physician Group - Southfield /ID# 210245
  • Private practice: Dr. Rex G. Mabey JR /ID# 211149
  • Dr. Nader and Associates M.D. P.C. /ID# 211150
  • Cooper University Hospital/Sheridan Pavilion /ID# 205576
  • University of New Mexico /ID# 212594
  • SUNY Downstate Medical Center /ID# 211180
  • University of Rochester - Strong Fertility Center - Rochester /ID# 210328
  • OB.GYN Associates of WNY /ID# 210765
  • Upstate Clinical Research Associates /ID# 205717
  • Carolina Institute for Clinical Research - Fayetteville /ID# 211319
  • Wake Forest Baptist Medical Center /ID# 211473
  • Duplicate_Aventiv Research, Inc. /ID# 205460
  • Univ Hosp Landerbrook /ID# 205558
  • AC Clinical Research /ID# 205492
  • Penn State University and Milton S. Hershey Medical Center /ID# 205555
  • Thomas Jefferson University /ID# 205614
  • Reading Hospital /ID# 211322
  • Chattanooga Medical Research /ID# 215190
  • WR-Medical Research Center of Memphis LLC /ID# 205636
  • The University of Texas Southwestern Medical Center /ID# 210804
  • University of Texas (UT) Health Women's Research Center at Memorial City /ID# 216266
  • Advances in Health, Inc. /ID# 211249
  • Duplicate_Diagnostic Clinic of Longview /ID# 211019
  • Center of Reproductive Medicine /ID# 211250
  • Virginia Mason - Seattle Orthapedics /ID# 205586
  • Seattle Women's Health, Research, Gynecology /ID# 205569
  • North Spokane Women's Health /ID# 205585
  • Puerto Rico Medical Research /ID# 211104
  • University of Puerto Rico, Medical Sciences Campus /ID# 212320
  • Duplicate_Rodriguez-Ginorio, San Juan /ID# 211105
  • Mindful Medical Research /ID# 212323

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Elagolix 25 mg BID

Elagolix 50 mg Once Daily (QD)

Elagolix 75 mg BID

Elagolix 150 mg QD

Elagolix 300 mg QD

Arm Description

Placebo taken orally twice a day (BID)

Elagolix 25 mg taken orally BID plus placebo

Elagolix 50 mg taken orally QD plus placebo

Elagolix 75 mg taken orally BID plus placebo

Elagolix 150 mg taken orally QD plus placebo

Elagolix 300 mg taken orally QD plus placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1

Full Information

First Posted
May 6, 2019
Last Updated
May 16, 2022
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03951077
Brief Title
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Official Title
Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).
Detailed Description
This is a phase 2, multicenter, double-blind (sponsor-unblinded), randomized, placebo-controlled study to assess the safety and efficacy of elagolix in women with PCOS. PCOS is one of the most common hormonal disorders in women of reproductive age, yet few treatment options are available. This study will help determine if elagolix can impact disordered hormonal dynamics in women with PCOS and at what dosage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic Ovary Syndrome, Hormone, Elagolix

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo taken orally twice a day (BID)
Arm Title
Elagolix 25 mg BID
Arm Type
Experimental
Arm Description
Elagolix 25 mg taken orally BID plus placebo
Arm Title
Elagolix 50 mg Once Daily (QD)
Arm Type
Experimental
Arm Description
Elagolix 50 mg taken orally QD plus placebo
Arm Title
Elagolix 75 mg BID
Arm Type
Experimental
Arm Description
Elagolix 75 mg taken orally BID plus placebo
Arm Title
Elagolix 150 mg QD
Arm Type
Experimental
Arm Description
Elagolix 150 mg taken orally QD plus placebo
Arm Title
Elagolix 300 mg QD
Arm Type
Experimental
Arm Description
Elagolix 300 mg taken orally QD plus placebo
Intervention Type
Drug
Intervention Name(s)
Elagolix
Other Intervention Name(s)
Orilissa
Intervention Description
Capsule administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule administered orally
Primary Outcome Measure Information:
Title
Percentage of Menstrual Cycle Responders
Description
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.
Time Frame
Week 0 (Baseline) to Week 24 (Month 6)
Secondary Outcome Measure Information:
Title
Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1
Time Frame
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics /ID# 211498
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235-3430
Country
United States
Facility Name
Mobile, OBGYN P.C. /ID# 205574
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Medical Ctr for Clin Research /ID# 205694
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
UCSF Center for Reproductive Health /ID# 210836
City
San Francisco
State/Province
California
ZIP/Postal Code
94158-2518
Country
United States
Facility Name
Avail Clinical Research /ID# 210873
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720-0834
Country
United States
Facility Name
University of FL Southside Women's Specialists /ID# 210872
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207-4918
Country
United States
Facility Name
Segal Institute for Clinical Research /ID# 205490
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161-5821
Country
United States
Facility Name
A Premier Medical Research of FL /ID# 215659
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763-2833
Country
United States
Facility Name
Virtus Research Consultant,LLC /ID# 205475
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Comprehensive Clinical Trials LLC /ID# 205458
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Mount Vernon Clinical Res, LLC /ID# 205695
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Bingham Memorial Hospital /ID# 205606
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Leavitt Womens Healthcare /ID# 205571
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-8322
Country
United States
Facility Name
Womens Healthcare Assoc, DBA /ID# 211528
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Sonora Clinical Research /ID# 205623
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646-1144
Country
United States
Facility Name
Asr, Llc /Id# 207037
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
PRN Professional Research Network of Kansas, LLC /ID# 205875
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Clinical Trials Management, LLC - Covington /ID# 211219
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Clinical Trials Management, LLC - Metairie /ID# 205494
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006-4165
Country
United States
Facility Name
Baltimore Suburban Health /ID# 205619
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Johns Hopkins University /ID# 205617
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Capital Women's Care - Frederi /ID# 210276
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
NECCR Fall River LLC /ID# 205567
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720-2972
Country
United States
Facility Name
Wayne State University Physician Group - Southfield /ID# 210245
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Private practice: Dr. Rex G. Mabey JR /ID# 211149
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Dr. Nader and Associates M.D. P.C. /ID# 211150
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030-7187
Country
United States
Facility Name
Cooper University Hospital/Sheridan Pavilion /ID# 205576
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053-3464
Country
United States
Facility Name
University of New Mexico /ID# 212594
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102-4517
Country
United States
Facility Name
SUNY Downstate Medical Center /ID# 211180
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
University of Rochester - Strong Fertility Center - Rochester /ID# 210328
City
Rochester
State/Province
New York
ZIP/Postal Code
14623-4284
Country
United States
Facility Name
OB.GYN Associates of WNY /ID# 210765
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Upstate Clinical Research Associates /ID# 205717
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221-6046
Country
United States
Facility Name
Carolina Institute for Clinical Research - Fayetteville /ID# 211319
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Facility Name
Wake Forest Baptist Medical Center /ID# 211473
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Facility Name
Duplicate_Aventiv Research, Inc. /ID# 205460
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Univ Hosp Landerbrook /ID# 205558
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
AC Clinical Research /ID# 205492
City
Tiffin
State/Province
Ohio
ZIP/Postal Code
44883
Country
United States
Facility Name
Penn State University and Milton S. Hershey Medical Center /ID# 205555
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Facility Name
Thomas Jefferson University /ID# 205614
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Reading Hospital /ID# 211322
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Chattanooga Medical Research /ID# 215190
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
WR-Medical Research Center of Memphis LLC /ID# 205636
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120-8328
Country
United States
Facility Name
The University of Texas Southwestern Medical Center /ID# 210804
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8575
Country
United States
Facility Name
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 216266
City
Houston
State/Province
Texas
ZIP/Postal Code
77024-2515
Country
United States
Facility Name
Advances in Health, Inc. /ID# 211249
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Duplicate_Diagnostic Clinic of Longview /ID# 211019
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Center of Reproductive Medicine /ID# 211250
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Virginia Mason - Seattle Orthapedics /ID# 205586
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Seattle Women's Health, Research, Gynecology /ID# 205569
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
North Spokane Women's Health /ID# 205585
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Puerto Rico Medical Research /ID# 211104
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
University of Puerto Rico, Medical Sciences Campus /ID# 212320
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Duplicate_Rodriguez-Ginorio, San Juan /ID# 211105
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Mindful Medical Research /ID# 212323
City
San Juan
ZIP/Postal Code
00918-3756
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

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