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

Phase 2

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Elagolix; Drug: Placebo

• Registration Number: NCT03951077
• Lead Sponsor: AbbVie

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.

Study Timeline

• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-15
• Study Start: 2019-08-12
• Primary Completion: 2021-02-10
• Study Completion: 2021-02-10
• Disposition First Submitted: 2021-12-27
• Disposition First Submitted QC: 2021-12-27
• Disposition First Posted: 2021-12-29
• Status Verified: 2022-05
• Results First Submitted: 2022-05-16
• Results First Submitted QC: 2022-05-16
• Last Update Submitted: 2022-05-16
• Results First Posted: 2022-06-08
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elagolix 75 mg BID	Placebo	Elagolix 75 mg taken orally BID plus placebo
Placebo	Placebo	Placebo taken orally twice a day (BID)
Elagolix 25 mg BID	Placebo	Elagolix 25 mg taken orally BID plus placebo
Elagolix 50 mg Once Daily (QD)	Placebo	Elagolix 50 mg taken orally QD plus placebo
Elagolix 150 mg QD	Placebo	Elagolix 150 mg taken orally QD plus placebo
Elagolix 300 mg QD	Placebo	Elagolix 300 mg taken orally QD plus placebo
Elagolix 150 mg QD	Elagolix	Elagolix 150 mg taken orally QD plus placebo
Elagolix 25 mg BID	Elagolix	Elagolix 25 mg taken orally BID plus placebo
Elagolix 50 mg Once Daily (QD)	Elagolix	Elagolix 50 mg taken orally QD plus placebo
Elagolix 75 mg BID	Elagolix	Elagolix 75 mg taken orally BID plus placebo
Elagolix 300 mg QD	Elagolix	Elagolix 300 mg taken orally QD plus placebo

Primary Outcome Measures

Name	Time	Method
Percentage of Menstrual Cycle Responders	Week 0 (Baseline) to Week 24 (Month 6)	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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (54)

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

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