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

AbbVie118 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

118

Conditions

Polycystic Ovary Syndrome

Interventions

ElagolixDRUG

Capsule administered orally

PlaceboDRUG

Capsule administered orally

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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).

Locations (54)

Outcomes

Primary Outcomes

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.

Time frame: Week 0 (Baseline) to Week 24 (Month 6)

Secondary Outcomes

Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1

Time frame: 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.

Data from ClinicalTrials.gov

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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

...and 44 more locations