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

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

Detailed Description
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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.

Official Title
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Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Elagolix
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo taken orally twice a day (BID) | Drug: Placebo<br>* Capsule administered orally<br>|
| Experimental: Elagolix 25 mg BID<br>Elagolix 25 mg taken orally BID plus placebo | Drug: Elagolix<br>* Capsule administered orally<br>* Other names: Orilissa;Drug: Placebo<br>* Capsule administered orally<br>|
| Experimental: Elagolix 50 mg Once Daily (QD)<br>Elagolix 50 mg taken orally QD plus placebo | Drug: Elagolix<br>* Capsule administered orally<br>* Other names: Orilissa;Drug: Placebo<br>* Capsule administered orally<br>|
| Experimental: Elagolix 75 mg BID<br>Elagolix 75 mg taken orally BID plus placebo | Drug: Elagolix<br>* Capsule administered orally<br>* Other names: Orilissa;Drug: Placebo<br>* Capsule administered orally<br>|
| Experimental: Elagolix 150 mg QD<br>Elagolix 150 mg taken orally QD plus placebo | Drug: Elagolix<br>* Capsule administered orally<br>* Other names: Orilissa;Drug: Placebo<br>* Capsule administered orally<br>|
| Experimental: Elagolix 300 mg QD<br>Elagolix 300 mg taken orally QD plus placebo | Drug: Elagolix<br>* Capsule administered orally<br>* Other names: Orilissa;Drug: Placebo<br>* Capsule administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, Hormone, Elagolix