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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951077
• Other study ID #: M16-837
• Status: Completed
• Phase: Phase 2
• Start date: August 12, 2019
• Est. completion date: February 10, 2021

Study information

• Verified date: May 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Elagolix
Capsule administered orally
• Placebo
Capsule administered orally

Locations

Country	Name	City	State
Puerto Rico	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
United States	University of New Mexico /ID# 212594	Albuquerque	New Mexico
United States	Mount Vernon Clinical Res, LLC /ID# 205695	Atlanta	Georgia
United States	Baltimore Suburban Health /ID# 205619	Baltimore	Maryland
United States	Johns Hopkins University /ID# 205617	Baltimore	Maryland
United States	Alabama Clinical Therapeutics /ID# 211498	Birmingham	Alabama
United States	Bingham Memorial Hospital /ID# 205606	Blackfoot	Idaho
United States	SUNY Downstate Medical Center /ID# 211180	Brooklyn	New York
United States	Chattanooga Medical Research /ID# 215190	Chattanooga	Tennessee
United States	Duplicate_Aventiv Research, Inc. /ID# 205460	Columbus	Ohio
United States	Clinical Trials Management, LLC - Covington /ID# 211219	Covington	Louisiana
United States	The University of Texas Southwestern Medical Center /ID# 210804	Dallas	Texas
United States	Avail Clinical Research /ID# 210873	DeLand	Florida
United States	NECCR Fall River LLC /ID# 205567	Fall River	Massachusetts
United States	Carolina Institute for Clinical Research - Fayetteville /ID# 211319	Fayetteville	North Carolina
United States	Capital Women's Care - Frederi /ID# 210276	Frederick	Maryland
United States	Penn State University and Milton S. Hershey Medical Center /ID# 205555	Hershey	Pennsylvania
United States	Advances in Health, Inc. /ID# 211249	Houston	Texas
United States	University of Texas (UT) Health Women's Research Center at Memorial City /ID# 216266	Houston	Texas
United States	Leavitt Womens Healthcare /ID# 205571	Idaho Falls	Idaho
United States	Womens Healthcare Assoc, DBA /ID# 211528	Idaho Falls	Idaho
United States	University of FL Southside Women's Specialists /ID# 210872	Jacksonville	Florida
United States	Private practice: Dr. Rex G. Mabey JR /ID# 211149	Las Vegas	Nevada
United States	Duplicate_Diagnostic Clinic of Longview /ID# 211019	Longview	Texas
United States	Cooper University Hospital/Sheridan Pavilion /ID# 205576	Marlton	New Jersey
United States	Univ Hosp Landerbrook /ID# 205558	Mayfield Heights	Ohio
United States	WR-Medical Research Center of Memphis LLC /ID# 205636	Memphis	Tennessee
United States	Sonora Clinical Research /ID# 205623	Meridian	Idaho
United States	Clinical Trials Management, LLC - Metairie /ID# 205494	Metairie	Louisiana
United States	Mobile, OBGYN P.C. /ID# 205574	Mobile	Alabama
United States	Asr, Llc /Id# 207037	Nampa	Idaho
United States	Dr. Nader and Associates M.D. P.C. /ID# 211150	North Las Vegas	Nevada
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	Thomas Jefferson University /ID# 205614	Philadelphia	Pennsylvania
United States	Reading Hospital /ID# 211322	Reading	Pennsylvania
United States	University of Rochester - Strong Fertility Center - Rochester /ID# 210328	Rochester	New York
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	Seattle Women's Health, Research, Gynecology /ID# 205569	Seattle	Washington
United States	Virginia Mason - Seattle Orthapedics /ID# 205586	Seattle	Washington
United States	Wayne State University Physician Group - Southfield /ID# 210245	Southfield	Michigan
United States	North Spokane Women's Health /ID# 205585	Spokane	Washington
United States	AC Clinical Research /ID# 205492	Tiffin	Ohio
United States	Center of Reproductive Medicine /ID# 211250	Webster	Texas
United States	Virtus Research Consultant,LLC /ID# 205475	Wellington	Florida
United States	Comprehensive Clinical Trials LLC /ID# 205458	West Palm Beach	Florida
United States	OB.GYN Associates of WNY /ID# 210765	West Seneca	New York
United States	PRN Professional Research Network of Kansas, LLC /ID# 205875	Wichita	Kansas
United States	Upstate Clinical Research Associates /ID# 205717	Williamsville	New York
United States	Wake Forest Baptist Medical Center /ID# 211473	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Menstrual Cycle Responders	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.	Week 0 (Baseline) to Week 24 (Month 6)
Secondary	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.

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.