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

This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Elagolix

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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Puerto Rico Medical Research /ID# 211104
  • Rio Piedras, Puerto Rico, 00935
    • University of Puerto Rico, Medical Sciences Campus /ID# 212320
  • San Juan, Puerto Rico, 00917
    • Duplicate_Rodriguez-Ginorio, San Juan /ID# 211105
  • San Juan, Puerto Rico, 00918-3756
    • Mindful Medical Research /ID# 212323
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235-3430
      • Alabama Clinical Therapeutics /ID# 211498
    • Mobile, Alabama, United States, 36608
      • Mobile, OBGYN P.C. /ID# 205574
  • California
    • San Diego, California, United States, 92108
      • Medical Ctr for Clin Research /ID# 205694
    • San Francisco, California, United States, 94158-2518
      • UCSF Center for Reproductive Health /ID# 210836
  • Florida
    • DeLand, Florida, United States, 32720-0834
      • Avail Clinical Research /ID# 210873
    • Jacksonville, Florida, United States, 32207-4918
      • University of FL Southside Women's Specialists /ID# 210872
    • North Miami, Florida, United States, 33161-5821
      • Segal Institute for Clinical Research /ID# 205490
    • Orange City, Florida, United States, 32763-2833
      • A Premier Medical Research of FL /ID# 215659
    • Wellington, Florida, United States, 33414
      • Virtus Research Consultant,LLC /ID# 205475
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trials LLC /ID# 205458
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Mount Vernon Clinical Res, LLC /ID# 205695
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Bingham Memorial Hospital /ID# 205606
    • Idaho Falls, Idaho, United States, 83404-8322
      • Leavitt Womens Healthcare /ID# 205571
    • Idaho Falls, Idaho, United States, 83404
      • Womens Healthcare Assoc, DBA /ID# 211528
    • Meridian, Idaho, United States, 83646-1144
      • Sonora Clinical Research /ID# 205623
    • Nampa, Idaho, United States, 83687
      • Asr, Llc /Id# 207037
  • Kansas
    • Wichita, Kansas, United States, 67205
      • PRN Professional Research Network of Kansas, LLC /ID# 205875
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Clinical Trials Management, LLC - Covington /ID# 211219
    • Metairie, Louisiana, United States, 70006-4165
      • Clinical Trials Management, LLC - Metairie /ID# 205494
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Baltimore Suburban Health /ID# 205619
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University /ID# 205617
    • Frederick, Maryland, United States, 21702
      • Capital Women's Care - Frederi /ID# 210276
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720-2972
      • NECCR Fall River LLC /ID# 205567
  • Michigan
    • Southfield, Michigan, United States, 48034
      • Wayne State University Physician Group - Southfield /ID# 210245
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Private practice: Dr. Rex G. Mabey JR /ID# 211149
    • North Las Vegas, Nevada, United States, 89030-7187
      • Dr. Nader and Associates M.D. P.C. /ID# 211150
  • New Jersey
    • Marlton, New Jersey, United States, 08053-3464
      • Cooper University Hospital/Sheridan Pavilion /ID# 205576
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102-4517
      • University of New Mexico /ID# 212594
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center /ID# 211180
    • Rochester, New York, United States, 14623-4284
      • University of Rochester - Strong Fertility Center - Rochester /ID# 210328
    • West Seneca, New York, United States, 14224
      • OB.GYN Associates of WNY /ID# 210765
    • Williamsville, New York, United States, 14221-6046
      • Upstate Clinical Research Associates /ID# 205717
  • North Carolina
    • Fayetteville, North Carolina, United States, 28303
      • Carolina Institute for Clinical Research - Fayetteville /ID# 211319
    • Winston-Salem, North Carolina, United States, 27157-0001
      • Wake Forest Baptist Medical Center /ID# 211473
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Duplicate_Aventiv Research, Inc. /ID# 205460
    • Mayfield Heights, Ohio, United States, 44124
      • Univ Hosp Landerbrook /ID# 205558
    • Tiffin, Ohio, United States, 44883
      • AC Clinical Research /ID# 205492
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-2360
      • Penn State University and Milton S. Hershey Medical Center /ID# 205555
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University /ID# 205614
    • Reading, Pennsylvania, United States, 19611
      • Reading Hospital /ID# 211322
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research /ID# 215190
    • Memphis, Tennessee, United States, 38120-8328
      • WR-Medical Research Center of Memphis LLC /ID# 205636
  • Texas
    • Dallas, Texas, United States, 75390-8575
      • The University of Texas Southwestern Medical Center /ID# 210804
    • Houston, Texas, United States, 77024-2515
      • University of Texas (UT) Health Women's Research Center at Memorial City /ID# 216266
    • Houston, Texas, United States, 77030
      • Advances in Health, Inc. /ID# 211249
    • Longview, Texas, United States, 75605
      • Duplicate_Diagnostic Clinic of Longview /ID# 211019
    • Webster, Texas, United States, 77598
      • Center of Reproductive Medicine /ID# 211250
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason - Seattle Orthapedics /ID# 205586
    • Seattle, Washington, United States, 98105
      • Seattle Women's Health, Research, Gynecology /ID# 205569
    • Spokane, Washington, United States, 99207
      • North Spokane Women's Health /ID# 205585

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo taken orally twice a day (BID)	Drug: Placebo; Capsule administered orally
Experimental: Elagolix 25 mg BID; Elagolix 25 mg taken orally BID plus placebo	Drug: Placebo; Capsule administered orally; Drug: Elagolix; Capsule administered orally; Other Names: Orilissa
Experimental: Elagolix 50 mg Once Daily (QD); Elagolix 50 mg taken orally QD plus placebo	Drug: Placebo; Capsule administered orally; Drug: Elagolix; Capsule administered orally; Other Names: Orilissa
Experimental: Elagolix 75 mg BID; Elagolix 75 mg taken orally BID plus placebo	Drug: Placebo; Capsule administered orally; Drug: Elagolix; Capsule administered orally; Other Names: Orilissa
Experimental: Elagolix 150 mg QD; Elagolix 150 mg taken orally QD plus placebo	Drug: Placebo; Capsule administered orally; Drug: Elagolix; Capsule administered orally; Other Names: Orilissa
Experimental: Elagolix 300 mg QD; Elagolix 300 mg taken orally QD plus placebo	Drug: Placebo; Capsule administered orally; Drug: Elagolix; Capsule administered orally; Other Names: Orilissa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Polycystic Ovary Syndrome; Elagolix; Hormone
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: M16-837

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• 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