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

May 16, 2022 updated by: AbbVie

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 31 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Menstrual Cycle Responders
Time Frame: Week 0 (Baseline) to Week 24 (Month 6)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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