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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03951077
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study will assess the potential impact of Elagolix on disordered pituitary and ovarian hormones in women with Polycystic Ovary Syndrome (PCOS).

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Elagolix Drug: Placebo Phase 2

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 polycystic ovary syndrome (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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 22, 2019
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : April 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Various doses of Elagolix plus matching placebo
Various dosing regimens for Elagolix taken orally plus matching placebo taken orally depending on arm assignment.
Drug: Elagolix
Capsule administered orally
Other Name: Orilissa

Drug: Placebo
Capsule administered orally

Placebo Comparator: Placebo
Placebo taken orally twice a day (BID)
Drug: Placebo
Capsule administered orally




Primary Outcome Measures :
  1. Percentage of Menstrual Cycle Responders [ Time Frame: Week 0 (Baseline) to Week 24 ]
    Menstrual cycle improvement will be assessed by the participant's e-diary.


Secondary Outcome Measures :
  1. Change in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) [ Time Frame: Week 0 (Baseline) to Week 1 ]
    Demonstrates the effects of the drug on the rate at which the hormones are formed and eliminated by the participant's body.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with clinical diagnosis of Polycystic Ovary Syndrome (PCOS)
  • Participants with a Body Mass Index (BMI) of 18.5 to 35 kg/m2 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 may 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)
  • Participants with surgical history of hysterectomy, unilateral or bilateral oophorectomy, bilateral tubal ligation, bilateral tubal occlusion, or bilateral salpingectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951077


  Hide Study Locations
Locations
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United States, Alabama
Alabama Clinical Therapeutics, LLC /ID# 211498 Not yet recruiting
Birmingham, Alabama, United States, 35235-3430
Mobile, Ob-Gyn, P.C. /ID# 205574 Not yet recruiting
Mobile, Alabama, United States, 36608
United States, California
University of California, Los Angeles /ID# 205713 Not yet recruiting
Los Angeles, California, United States, 90095
Medical Ctr for Clin Research /ID# 205694 Not yet recruiting
San Diego, California, United States, 92108
West Coast Medical Research, I /ID# 205613 Not yet recruiting
San Diego, California, United States, 92123-3357
UCSF Center for Reproductive Health /ID# 210836 Not yet recruiting
San Francisco, California, United States, 94158-2518
United States, Florida
Avail Clinical Research /ID# 210873 Not yet recruiting
DeLand, Florida, United States, 32720-0834
University of FL Southside Women's Specialists /ID# 210872 Not yet recruiting
Jacksonville, Florida, United States, 32207-4918
Segal Institute for Clinical Research /ID# 205490 Not yet recruiting
North Miami, Florida, United States, 33161-5821
Virtus Research Consultant,LLC /ID# 205475 Not yet recruiting
Wellington, Florida, United States, 33414
Comprehensive Clinical Trials /ID# 205458 Not yet recruiting
West Palm Beach, Florida, United States, 33409
United States, Georgia
Mount Vernon Clinical Res, LLC /ID# 205695 Not yet recruiting
Atlanta, Georgia, United States, 30328
United States, Idaho
Bingham Memorial Hospital /ID# 205606 Not yet recruiting
Blackfoot, Idaho, United States, 83221
Leavitt Womens Healthcare /ID# 205571 Not yet recruiting
Idaho Falls, Idaho, United States, 83404-8322
Womens Healthcare Assoc, DBA /ID# 211528 Not yet recruiting
Idaho Falls, Idaho, United States, 83404
Asr, Llc /Id# 207037 Not yet recruiting
Nampa, Idaho, United States, 83687
United States, Indiana
Women's Health Care, PC /ID# 205615 Not yet recruiting
Newburgh, Indiana, United States, 47630-8940
United States, Kansas
PRN Professional Research Network of Kansas, LLC /ID# 205875 Not yet recruiting
Wichita, Kansas, United States, 67205
United States, Louisiana
Clinical Trials Management,LLC /ID# 211219 Not yet recruiting
Covington, Louisiana, United States, 70433
Clinical Trials Management, LLC - Metairie /ID# 205494 Not yet recruiting
Metairie, Louisiana, United States, 70006-4165
Louisiana State University in /ID# 204958 Not yet recruiting
Shreveport, Louisiana, United States, 71130
United States, Maryland
Baltimore Suburban Health /ID# 205619 Not yet recruiting
Baltimore, Maryland, United States, 21208
Johns Hopkins University /ID# 205617 Not yet recruiting
Baltimore, Maryland, United States, 21287
Capital Women's Care - Frederi /ID# 210276 Not yet recruiting
Frederick, Maryland, United States, 21702
United States, Massachusetts
Neccr /Id# 205567 Not yet recruiting
Fall River, Massachusetts, United States, 02720-2972
United States, Michigan
Wayne State University Physician Group - Southfield /ID# 210245 Not yet recruiting
Southfield, Michigan, United States, 48034
United States, Nevada
Mabey, Las Vegas, NV /ID# 211149 Not yet recruiting
Las Vegas, Nevada, United States, 89128
Dr. Nader and Associates M.D. P.C. /ID# 211150 Not yet recruiting
North Las Vegas, Nevada, United States, 89030-7187
United States, New Jersey
Cooper University Health Care - Marlton /ID# 205576 Not yet recruiting
Marlton, New Jersey, United States, 08053-3464
United States, New York
SUNY Downstate Medical Center /ID# 211180 Not yet recruiting
Brooklyn, New York, United States, 11203
University of Rochester - Strong Fertility Center - Rochester /ID# 210328 Not yet recruiting
Rochester, New York, United States, 14623-4284
OB.GYN Associates of WNY /ID# 210765 Not yet recruiting
West Seneca, New York, United States, 14224
Upstate Clinical Research Associates /ID# 205717 Not yet recruiting
Williamsville, New York, United States, 14221-6046
United States, North Carolina
Omega Research Consultants, LL /ID# 211319 Not yet recruiting
Fayetteville, North Carolina, United States, 28304
Wake Forest Baptist Medical Center /ID# 211473 Not yet recruiting
Winston-Salem, North Carolina, United States, 27157-0001
United States, Ohio
Rapid Medical Research, INC /ID# 205643 Not yet recruiting
Cleveland, Ohio, United States, 44122
Aventiv Research, Inc. /ID# 205460 Not yet recruiting
Columbus, Ohio, United States, 43213
HWC Women's Research Center /ID# 211128 Not yet recruiting
Englewood, Ohio, United States, 45322
Univ Hosp Landerbrook /ID# 205558 Not yet recruiting
Mayfield Heights, Ohio, United States, 44124
AC Clinical Research /ID# 205492 Not yet recruiting
Tiffin, Ohio, United States, 44883
United States, Pennsylvania
Penn State University and Milton S. Hershey Medical Center /ID# 205555 Not yet recruiting
Hershey, Pennsylvania, United States, 17033-2360
Thomas Jefferson University /ID# 205614 Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Reading Hosp Clncl Trials Ofc /ID# 211322 Not yet recruiting
West Reading, Pennsylvania, United States, 19611
United States, Tennessee
Adams Patterson Gyn & Obs /ID# 205636 Not yet recruiting
Memphis, Tennessee, United States, 38120
United States, Texas
Advances in Health, Inc. /ID# 211249 Not yet recruiting
Houston, Texas, United States, 77030
Diagnostic Clinic of Longview /ID# 211019 Not yet recruiting
Longview, Texas, United States, 75605
Progressive Clinical Research /ID# 211165 Not yet recruiting
San Antonio, Texas, United States, 78229
Center of Reproductive Medicin /ID# 211250 Not yet recruiting
Webster, Texas, United States, 77598
United States, Washington
Virginia Mason Medical Center /ID# 205586 Not yet recruiting
Seattle, Washington, United States, 98101
Seattle Women's Health, Research, Gynecology /ID# 205569 Not yet recruiting
Seattle, Washington, United States, 98105
North Spokane Women's Health /ID# 205585 Not yet recruiting
Spokane, Washington, United States, 99207
Madigan Army Medical Center /ID# 211018 Not yet recruiting
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03951077     History of Changes
Other Study ID Numbers: M16-837
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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

Keywords provided by AbbVie:
Polycystic Ovary Syndrome
Hormone
Elagolix

Additional relevant MeSH terms:
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Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases