An Open-label Trial Investigating the PK of Gonadotropin Releasing Hormone (GnRH) Administrated Subcutaneously Via the OmniPod Delivery System in Healthy Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Cmax: maximum observed plasma concentration from Part 1- Pulse 1
研究概览
简要总结
One of the Causes of Amenorrhea is hypothalamic amenorrhea, which is a deficiency in the amplitude and/or frequency of endogenous Gonadotropin-releasing hormone (GnRH) Pulses. The results of this leads to anovulation and cessation of the menstrual cycle. Pulsatile GnRH has been widely used in the United States (US), Canada, and Europe for almost 40 years in the treatment of primary hypothalamic amenorrhea. It has a favorable safety profile and a high degree of effectiveness in enabling ovulation and spontaneous pregnancy. At the moment there are no other GnRH products on the market, nor are there any other drugs marketed for induction of ovulation in women with primary hypothalamic amenorrhea in the US, creating a clear unmet medical need. The goal of this trial is to characterize the exposure variability of GnRH when administered via the OmniPod.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects 18 to 40 years old (both included).
- •Body mass index (BMI) between 18 and 30 kg/m2 (both included).
- •Regular menstrual cycles of 24 to 35 days (both included).
- •Exclusion Criteria
- •Any medical condition, which in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, or excretion of gonadotropin-releasing hormone (GnRH).
- •Use of any hormonal contraceptives, growth hormone, insulin or thyroid hormone replacement therapy 30 days prior to dosing in this trial.
- •Previously known or suspected hypersensitivity to GnRH.
排除标准
- 未提供
研究组 & 干预措施
Group A (single dose)
Single-dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse
干预措施: Lutrepulse (Drug)
Group B (multiple doses)
Part 1 - Single dose (1 pulse) LUTREPULSE Omnipod 20ug/pulse Part 2 - multiple doses (6 pulse) LUTREPULSE Omnipod 20ug/pulse
干预措施: Lutrepulse (Drug)
结局指标
主要结局
Cmax: maximum observed plasma concentration from Part 1- Pulse 1
时间窗: Up to 5 days
AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 1- Pulse 1
时间窗: Up to 5 days
AUC0-infinity: area under the concentration-time curve to infinity from Part 1- Pulse 1
时间窗: Up to 5 days
次要结局
- tmax: time to maximum plasma concentration from Part 1- Pulse 1(Up to 5 days)
- λz; terminal elimination rate constant from Part 1- Pulse 1(Up to 5 days)
- t½; terminal elimination half-life from Part 1- Pulse 1(Up to 5 days)
- Cmax: maximum observed plasma concentration from Part 2 - Pulse 6(Up to 4 days)
- AUC0-t: area under the concentration-time profile to the last quantified concentration from Part 2 - Pulse 6(Up to 4 days)
- AUCtau: area under the concentration-time profile at steady-state from Part 2 - Pulse 6(Up to 4 days)
- tmax: time to maximum plasma concentration from Part 2 - Pulse 6(Up to 4 days)
- λz; terminal elimination rate constant from Part 2 - Pulse 6(Up to 4 days)
- t½; terminal elimination half-life from Part 2 - Pulse 6(Up to 4 days)