Clinical trial NCT03951077: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Hormone
Elagolix
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-05-15
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Menstrual Cycle Responders
timeFrame: Week 0 (Baseline) to Week 24 (Month 6)
Secondary outcomes:
measure: Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1
timeFrame: 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.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics /ID# 211498
state: Alabama
city: Mobile
country: United States
facility: Mobile, OBGYN P.C. /ID# 205574
state: Alabama
city: San Diego
country: United States
facility: Medical Ctr for Clin Research /ID# 205694
state: California
city: San Francisco
country: United States
facility: UCSF Center for Reproductive Health /ID# 210836
state: California
city: DeLand
country: United States
facility: Avail Clinical Research /ID# 210873
state: Florida
city: Jacksonville
country: United States
facility: University of FL Southside Women's Specialists /ID# 210872
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research /ID# 205490
state: Florida
city: Orange City
country: United States
facility: A Premier Medical Research of FL /ID# 215659
state: Florida
city: Wellington
country: United States
facility: Virtus Research Consultant,LLC /ID# 205475
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials LLC /ID# 205458
state: Florida
city: Atlanta
country: United States
facility: Mount Vernon Clinical Res, LLC /ID# 205695
state: Georgia
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital /ID# 205606
state: Idaho
city: Idaho Falls
country: United States
facility: Leavitt Womens Healthcare /ID# 205571
state: Idaho
city: Idaho Falls
country: United States
facility: Womens Healthcare Assoc, DBA /ID# 211528
state: Idaho
city: Meridian
country: United States
facility: Sonora Clinical Research /ID# 205623
state: Idaho
city: Nampa
country: United States
facility: Asr, Llc /Id# 207037
state: Idaho
city: Wichita
country: United States
facility: PRN Professional Research Network of Kansas, LLC /ID# 205875
state: Kansas
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 211219
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC - Metairie /ID# 205494
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore Suburban Health /ID# 205619
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University /ID# 205617
state: Maryland
city: Frederick
country: United States
facility: Capital Women's Care - Frederi /ID# 210276
state: Maryland
city: Fall River
country: United States
facility: NECCR Fall River LLC /ID# 205567
state: Massachusetts
city: Southfield
country: United States
facility: Wayne State University Physician Group - Southfield /ID# 210245
state: Michigan
city: Las Vegas
country: United States
facility: Private practice: Dr. Rex G. Mabey JR /ID# 211149
state: Nevada
city: North Las Vegas
country: United States
facility: Dr. Nader and Associates M.D. P.C. /ID# 211150
state: Nevada
city: Marlton
country: United States
facility: Cooper University Hospital/Sheridan Pavilion /ID# 205576
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico /ID# 212594
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center /ID# 211180
state: New York
city: Rochester
country: United States
facility: University of Rochester - Strong Fertility Center - Rochester /ID# 210328
state: New York
city: West Seneca
country: United States
facility: OB.GYN Associates of WNY /ID# 210765
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates /ID# 205717
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research - Fayetteville /ID# 211319
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center /ID# 211473
state: North Carolina
city: Columbus
country: United States
facility: Duplicate_Aventiv Research, Inc. /ID# 205460
state: Ohio
city: Mayfield Heights
country: United States
facility: Univ Hosp Landerbrook /ID# 205558
state: Ohio
city: Tiffin
country: United States
facility: AC Clinical Research /ID# 205492
state: Ohio
city: Hershey
country: United States
facility: Penn State University and Milton S. Hershey Medical Center /ID# 205555
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University /ID# 205614
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital /ID# 211322
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga Medical Research /ID# 215190
state: Tennessee
city: Memphis
country: United States
facility: WR-Medical Research Center of Memphis LLC /ID# 205636
state: Tennessee
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center /ID# 210804
state: Texas
city: Houston
country: United States
facility: University of Texas (UT) Health Women's Research Center at Memorial City /ID# 216266
state: Texas
city: Houston
country: United States
facility: Advances in Health, Inc. /ID# 211249
state: Texas
city: Longview
country: United States
facility: Duplicate_Diagnostic Clinic of Longview /ID# 211019
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicine /ID# 211250
state: Texas
city: Seattle
country: United States
facility: Virginia Mason - Seattle Orthapedics /ID# 205586
state: Washington
city: Seattle
country: United States
facility: Seattle Women's Health, Research, Gynecology /ID# 205569
state: Washington
city: Spokane
country: United States
facility: North Spokane Women's Health /ID# 205585
state: Washington
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Research /ID# 211104
city: Rio Piedras
country: Puerto Rico
facility: University of Puerto Rico, Medical Sciences Campus /ID# 212320
city: San Juan
country: Puerto Rico
facility: Duplicate_Rodriguez-Ginorio, San Juan /ID# 211105
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 212323
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: