A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 486
- 试验地点
- 71
- 主要终点
- Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders
研究概览
简要总结
The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).
详细描述
This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women.
Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subject must have:
- •Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening.
- •Moderate to severe endometriosis-associated pain during the screening period.
- •Regular menstrual cycles.
- •BMI ≥ 18 kg/m2 at the screening visit. -
排除标准
- •The subject will be excluded if she:
- •Is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
- •Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period.
- •Has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
- •Did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
- •Has a history of, or known, osteoporosis or other metabolic bone disease.
- •Has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.
研究组 & 干预措施
Placebo
干预措施: Placebo tablet to match 75 mg linzagolix tablet (Drug)
Linzagolix 75 mg
干预措施: 75 mg linzagolix tablet (Drug)
Linzagolix 75 mg
干预措施: Placebo tablet to match 200 mg linzagolix tablet (Drug)
Linzagolix 75 mg
干预措施: Placebo capsule to match Add-back capsule (Drug)
Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)
干预措施: 200 mg linzagolix tablet (Drug)
Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)
干预措施: Add-back capsule (E2 1 mg / NETA 0.5 mg) (Drug)
Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)
干预措施: Placebo tablet to match 75 mg linzagolix tablet (Drug)
Placebo
干预措施: Placebo tablet to match 200 mg linzagolix tablet (Drug)
Placebo
干预措施: Placebo capsule to match Add-back capsule (Drug)
结局指标
主要结局
Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders
时间窗: Baseline to Month 3
Percentage of subjects with reduction of 1.1 for DYS in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Reduction of Non-menstrual Pelvic Pain (NMPP) at Month 3 - Proportion of Responders
时间窗: Baseline to Month 3
Percentage of subjects with reduction of 0.8 for NMPP in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
次要结局
未报告次要终点