Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
- Registration Number
- NCT03951077
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 118
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elagolix 75 mg BID Placebo Elagolix 75 mg taken orally BID plus placebo Placebo Placebo Placebo taken orally twice a day (BID) Elagolix 25 mg BID Placebo Elagolix 25 mg taken orally BID plus placebo Elagolix 50 mg Once Daily (QD) Placebo Elagolix 50 mg taken orally QD plus placebo Elagolix 150 mg QD Placebo Elagolix 150 mg taken orally QD plus placebo Elagolix 300 mg QD Placebo Elagolix 300 mg taken orally QD plus placebo Elagolix 150 mg QD Elagolix Elagolix 150 mg taken orally QD plus placebo Elagolix 25 mg BID Elagolix Elagolix 25 mg taken orally BID plus placebo Elagolix 50 mg Once Daily (QD) Elagolix Elagolix 50 mg taken orally QD plus placebo Elagolix 75 mg BID Elagolix Elagolix 75 mg taken orally BID plus placebo Elagolix 300 mg QD Elagolix Elagolix 300 mg taken orally QD plus placebo
- Primary Outcome Measures
Name Time Method Percentage of Menstrual Cycle Responders 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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (54)
Thomas Jefferson University /ID# 205614
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 216266
🇺🇸Houston, Texas, United States
Advances in Health, Inc. /ID# 211249
🇺🇸Houston, Texas, United States
Seattle Women's Health, Research, Gynecology /ID# 205569
🇺🇸Seattle, Washington, United States
Private practice: Dr. Rex G. Mabey JR /ID# 211149
🇺🇸Las Vegas, Nevada, United States
Medical Ctr for Clin Research /ID# 205694
🇺🇸San Diego, California, United States
UCSF Center for Reproductive Health /ID# 210836
🇺🇸San Francisco, California, United States
Dr. Nader and Associates M.D. P.C. /ID# 211150
🇺🇸North Las Vegas, Nevada, United States
University of FL Southside Women's Specialists /ID# 210872
🇺🇸Jacksonville, Florida, United States
Avail Clinical Research /ID# 210873
🇺🇸DeLand, Florida, United States
Alabama Clinical Therapeutics /ID# 211498
🇺🇸Birmingham, Alabama, United States
Mobile, OBGYN P.C. /ID# 205574
🇺🇸Mobile, Alabama, United States
Reading Hospital /ID# 211322
🇺🇸Reading, Pennsylvania, United States
Leavitt Womens Healthcare /ID# 205571
🇺🇸Idaho Falls, Idaho, United States
Wayne State University Physician Group - Southfield /ID# 210245
🇺🇸Southfield, Michigan, United States
The University of Texas Southwestern Medical Center /ID# 210804
🇺🇸Dallas, Texas, United States
Comprehensive Clinical Trials LLC /ID# 205458
🇺🇸West Palm Beach, Florida, United States
University of Rochester - Strong Fertility Center - Rochester /ID# 210328
🇺🇸Rochester, New York, United States
Duplicate_Diagnostic Clinic of Longview /ID# 211019
🇺🇸Longview, Texas, United States
Center of Reproductive Medicine /ID# 211250
🇺🇸Webster, Texas, United States
Womens Healthcare Assoc, DBA /ID# 211528
🇺🇸Idaho Falls, Idaho, United States
Mount Vernon Clinical Res, LLC /ID# 205695
🇺🇸Atlanta, Georgia, United States
Segal Institute for Clinical Research /ID# 205490
🇺🇸North Miami, Florida, United States
A Premier Medical Research of FL /ID# 215659
🇺🇸Orange City, Florida, United States
Virtus Research Consultant,LLC /ID# 205475
🇺🇸Wellington, Florida, United States
Duplicate_Aventiv Research, Inc. /ID# 205460
🇺🇸Columbus, Ohio, United States
Upstate Clinical Research Associates /ID# 205717
🇺🇸Williamsville, New York, United States
Clinical Trials Management, LLC - Metairie /ID# 205494
🇺🇸Metairie, Louisiana, United States
Carolina Institute for Clinical Research - Fayetteville /ID# 211319
🇺🇸Fayetteville, North Carolina, United States
Baltimore Suburban Health /ID# 205619
🇺🇸Baltimore, Maryland, United States
Puerto Rico Medical Research /ID# 211104
🇵🇷Ponce, Puerto Rico
Capital Women's Care - Frederi /ID# 210276
🇺🇸Frederick, Maryland, United States
NECCR Fall River LLC /ID# 205567
🇺🇸Fall River, Massachusetts, United States
Cooper University Hospital/Sheridan Pavilion /ID# 205576
🇺🇸Marlton, New Jersey, United States
Johns Hopkins University /ID# 205617
🇺🇸Baltimore, Maryland, United States
Virginia Mason - Seattle Orthapedics /ID# 205586
🇺🇸Seattle, Washington, United States
University of Puerto Rico, Medical Sciences Campus /ID# 212320
🇵🇷Rio Piedras, Puerto Rico
Mindful Medical Research /ID# 212323
🇵🇷San Juan, Puerto Rico
Univ Hosp Landerbrook /ID# 205558
🇺🇸Mayfield Heights, Ohio, United States
OB.GYN Associates of WNY /ID# 210765
🇺🇸West Seneca, New York, United States
Chattanooga Medical Research /ID# 215190
🇺🇸Chattanooga, Tennessee, United States
Asr, Llc /Id# 207037
🇺🇸Nampa, Idaho, United States
Sonora Clinical Research /ID# 205623
🇺🇸Meridian, Idaho, United States
WR-Medical Research Center of Memphis LLC /ID# 205636
🇺🇸Memphis, Tennessee, United States
North Spokane Women's Health /ID# 205585
🇺🇸Spokane, Washington, United States
Duplicate_Rodriguez-Ginorio, San Juan /ID# 211105
🇵🇷San Juan, Puerto Rico
University of New Mexico /ID# 212594
🇺🇸Albuquerque, New Mexico, United States
SUNY Downstate Medical Center /ID# 211180
🇺🇸Brooklyn, New York, United States
AC Clinical Research /ID# 205492
🇺🇸Tiffin, Ohio, United States
Penn State University and Milton S. Hershey Medical Center /ID# 205555
🇺🇸Hershey, Pennsylvania, United States
Wake Forest Baptist Medical Center /ID# 211473
🇺🇸Winston-Salem, North Carolina, United States
Bingham Memorial Hospital /ID# 205606
🇺🇸Blackfoot, Idaho, United States
PRN Professional Research Network of Kansas, LLC /ID# 205875
🇺🇸Wichita, Kansas, United States
Clinical Trials Management, LLC - Covington /ID# 211219
🇺🇸Covington, Louisiana, United States