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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 ID: NCT03951077
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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Alabama Clinical Therapeutics /ID# 211498, Birmingham, Alabama, United States
Mobile, OBGYN P.C. /ID# 205574, Mobile, Alabama, 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
Avail Clinical Research /ID# 210873, DeLand, Florida, United States
University of FL Southside Women's Specialists /ID# 210872, Jacksonville, Florida, 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
Comprehensive Clinical Trials LLC /ID# 205458, West Palm Beach, Florida, United States
Mount Vernon Clinical Res, LLC /ID# 205695, Atlanta, Georgia, United States
Bingham Memorial Hospital /ID# 205606, Blackfoot, Idaho, United States
Leavitt Womens Healthcare /ID# 205571, Idaho Falls, Idaho, United States
Womens Healthcare Assoc, DBA /ID# 211528, Idaho Falls, Idaho, United States
Sonora Clinical Research /ID# 205623, Meridian, Idaho, United States
Asr, Llc /Id# 207037, Nampa, 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
Clinical Trials Management, LLC - Metairie /ID# 205494, Metairie, Louisiana, United States
Baltimore Suburban Health /ID# 205619, Baltimore, Maryland, United States
Johns Hopkins University /ID# 205617, Baltimore, Maryland, United States
Capital Women's Care - Frederi /ID# 210276, Frederick, Maryland, United States
NECCR Fall River LLC /ID# 205567, Fall River, Massachusetts, United States
Wayne State University Physician Group - Southfield /ID# 210245, Southfield, Michigan, United States
Private practice: Dr. Rex G. Mabey JR /ID# 211149, Las Vegas, Nevada, United States
Dr. Nader and Associates M.D. P.C. /ID# 211150, North Las Vegas, Nevada, United States
Cooper University Hospital/Sheridan Pavilion /ID# 205576, Marlton, New Jersey, United States
University of New Mexico /ID# 212594, Albuquerque, New Mexico, United States
SUNY Downstate Medical Center /ID# 211180, Brooklyn, New York, United States
University of Rochester - Strong Fertility Center - Rochester /ID# 210328, Rochester, New York, United States
OB.GYN Associates of WNY /ID# 210765, West Seneca, New York, United States
Upstate Clinical Research Associates /ID# 205717, Williamsville, New York, United States
Carolina Institute for Clinical Research - Fayetteville /ID# 211319, Fayetteville, North Carolina, United States
Wake Forest Baptist Medical Center /ID# 211473, Winston-Salem, North Carolina, United States
Duplicate_Aventiv Research, Inc. /ID# 205460, Columbus, Ohio, United States
Univ Hosp Landerbrook /ID# 205558, Mayfield Heights, Ohio, 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
Thomas Jefferson University /ID# 205614, Philadelphia, Pennsylvania, United States
Reading Hospital /ID# 211322, Reading, Pennsylvania, United States
Chattanooga Medical Research /ID# 215190, Chattanooga, Tennessee, United States
WR-Medical Research Center of Memphis LLC /ID# 205636, Memphis, Tennessee, United States
The University of Texas Southwestern Medical Center /ID# 210804, Dallas, Texas, 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
Duplicate_Diagnostic Clinic of Longview /ID# 211019, Longview, Texas, United States
Center of Reproductive Medicine /ID# 211250, Webster, Texas, United States
Virginia Mason - Seattle Orthapedics /ID# 205586, Seattle, Washington, United States
Seattle Women's Health, Research, Gynecology /ID# 205569, Seattle, Washington, United States
North Spokane Women's Health /ID# 205585, Spokane, Washington, United States
Puerto Rico Medical Research /ID# 211104, Ponce, , Puerto Rico
University of Puerto Rico, Medical Sciences Campus /ID# 212320, Rio Piedras, , Puerto Rico
Duplicate_Rodriguez-Ginorio, San Juan /ID# 211105, San Juan, , Puerto Rico
Mindful Medical Research /ID# 212323, San Juan, , Puerto Rico
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR