Phase 2, Multicenter, Double-blind (Sponsor-unblinded), Randomized, Placebo-Controlled Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 54
- 主要终点
- Percentage of Menstrual Cycle Responders
研究概览
简要总结
This study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (PCOS).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Elagolix 150 mg QD
Elagolix 150 mg taken orally QD plus placebo
干预措施: Elagolix (Drug)
Placebo
Placebo taken orally twice a day (BID)
干预措施: Placebo (Drug)
Elagolix 25 mg BID
Elagolix 25 mg taken orally BID plus placebo
干预措施: Elagolix (Drug)
Elagolix 25 mg BID
Elagolix 25 mg taken orally BID plus placebo
干预措施: Placebo (Drug)
Elagolix 50 mg Once Daily (QD)
Elagolix 50 mg taken orally QD plus placebo
干预措施: Elagolix (Drug)
Elagolix 50 mg Once Daily (QD)
Elagolix 50 mg taken orally QD plus placebo
干预措施: Placebo (Drug)
Elagolix 75 mg BID
Elagolix 75 mg taken orally BID plus placebo
干预措施: Elagolix (Drug)
Elagolix 75 mg BID
Elagolix 75 mg taken orally BID plus placebo
干预措施: Placebo (Drug)
Elagolix 150 mg QD
Elagolix 150 mg taken orally QD plus placebo
干预措施: Placebo (Drug)
Elagolix 300 mg QD
Elagolix 300 mg taken orally QD plus placebo
干预措施: Elagolix (Drug)
Elagolix 300 mg QD
Elagolix 300 mg taken orally QD plus placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Menstrual Cycle Responders
时间窗: 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.
次要结局
- 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.)