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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT03951077
Phase
PHASE2
Status
Completed

Conditions

  • Polycystic Ovary Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Elagolix — DRUG
    Capsule administered orally
  • Placebo — DRUG
    Capsule administered orally

Study Details

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

Key Dates

Start date
Aug 12, 2019
Status verified
May 2022
Primary completion
Feb 10, 2021
Completion
Feb 10, 2021

Study Design

Enrollment
118 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo taken orally twice a day (BID)
  • Experimental: Elagolix 25 mg BID
    Elagolix 25 mg taken orally BID plus placebo
  • Experimental: Elagolix 50 mg Once Daily (QD)
    Elagolix 50 mg taken orally QD plus placebo
  • Experimental: Elagolix 75 mg BID
    Elagolix 75 mg taken orally BID plus placebo
  • Experimental: Elagolix 150 mg QD
    Elagolix 150 mg taken orally QD plus placebo
  • Experimental: Elagolix 300 mg QD
    Elagolix 300 mg taken orally QD plus placebo

Primary Outcome Measure

Percentage of Menstrual Cycle Responders [ Time Frame: Week 0 (Baseline) to Week 24 (Month 6) ]

Locations (50)

FacilityCityStateZIPSite coordinators
Alabama Clinical Therapeutics /ID# 211498BirminghamAlabama35235-3430-
Mobile, OBGYN P.C. /ID# 205574MobileAlabama36608-
Medical Ctr for Clin Research /ID# 205694San DiegoCalifornia92108-
UCSF Center for Reproductive Health /ID# 210836San FranciscoCalifornia94158-2518-
Avail Clinical Research /ID# 210873DeLandFlorida32720-0834-
University of FL Southside Women's Specialists /ID# 210872JacksonvilleFlorida32207-4918-
Segal Institute for Clinical Research /ID# 205490North MiamiFlorida33161-5821-
A Premier Medical Research of FL /ID# 215659Orange CityFlorida32763-2833-
Virtus Research Consultant,LLC /ID# 205475WellingtonFlorida33414-
Comprehensive Clinical Trials LLC /ID# 205458West Palm BeachFlorida33409-
Mount Vernon Clinical Res, LLC /ID# 205695AtlantaGeorgia30328-
Bingham Memorial Hospital /ID# 205606BlackfootIdaho83221-
Leavitt Womens Healthcare /ID# 205571Idaho FallsIdaho83404-8322-
Womens Healthcare Assoc, DBA /ID# 211528Idaho FallsIdaho83404-
Sonora Clinical Research /ID# 205623MeridianIdaho83646-1144-
Asr, Llc /Id# 207037NampaIdaho83687-
PRN Professional Research Network of Kansas, LLC /ID# 205875WichitaKansas67205-
Clinical Trials Management, LLC - Covington /ID# 211219CovingtonLouisiana70433-
Clinical Trials Management, LLC - Metairie /ID# 205494MetairieLouisiana70006-4165-
Baltimore Suburban Health /ID# 205619BaltimoreMaryland21208-
Johns Hopkins University /ID# 205617BaltimoreMaryland21287-
Capital Women's Care - Frederi /ID# 210276FrederickMaryland21702-
NECCR Fall River LLC /ID# 205567Fall RiverMassachusetts02720-2972-
Wayne State University Physician Group - Southfield /ID# 210245SouthfieldMichigan48034-
Private practice: Dr. Rex G. Mabey JR /ID# 211149Las VegasNevada89128-
Dr. Nader and Associates M.D. P.C. /ID# 211150North Las VegasNevada89030-7187-
Cooper University Hospital/Sheridan Pavilion /ID# 205576MarltonNew Jersey08053-3464-
University of New Mexico /ID# 212594AlbuquerqueNew Mexico87102-4517-
SUNY Downstate Medical Center /ID# 211180BrooklynNew York11203-
University of Rochester - Strong Fertility Center - Rochester /ID# 210328RochesterNew York14623-4284-
OB.GYN Associates of WNY /ID# 210765West SenecaNew York14224-
Upstate Clinical Research Associates /ID# 205717WilliamsvilleNew York14221-6046-
Carolina Institute for Clinical Research - Fayetteville /ID# 211319FayettevilleNorth Carolina28303-
Wake Forest Baptist Medical Center /ID# 211473Winston-SalemNorth Carolina27157-0001-
Duplicate_Aventiv Research, Inc. /ID# 205460ColumbusOhio43213-
Univ Hosp Landerbrook /ID# 205558Mayfield HeightsOhio44124-
AC Clinical Research /ID# 205492TiffinOhio44883-
Penn State University and Milton S. Hershey Medical Center /ID# 205555HersheyPennsylvania17033-2360-
Thomas Jefferson University /ID# 205614PhiladelphiaPennsylvania19107-
Reading Hospital /ID# 211322ReadingPennsylvania19611-
Chattanooga Medical Research /ID# 215190ChattanoogaTennessee37404-
WR-Medical Research Center of Memphis LLC /ID# 205636MemphisTennessee38120-8328-
The University of Texas Southwestern Medical Center /ID# 210804DallasTexas75390-8575-
Advances in Health, Inc. /ID# 211249HoustonTexas77030-
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 216266HoustonTexas77024-2515-
Duplicate_Diagnostic Clinic of Longview /ID# 211019LongviewTexas75605-
Center of Reproductive Medicine /ID# 211250WebsterTexas77598-
Seattle Women's Health, Research, Gynecology /ID# 205569SeattleWashington98105-
Virginia Mason - Seattle Orthapedics /ID# 205586SeattleWashington98101-
North Spokane Women's Health /ID# 205585SpokaneWashington99207-

Find similar trials in Birmingham, AL

By research site
Alabama Clinical Therapeutics· Birmingham, ALMobile, OBGYN P.C.· Mobile, ALMedical Ctr for Clin Research· San Diego, CAUCSF Center for Reproductive Health· San Francisco, CAAvail Clinical Research· DeLand, FLUniversity of FL Southside Women's Specialists· Jacksonville, FL

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