Pharmacodynamics (Suppression of Ovulation) and Pharmacokinetics Following a Single Subcutaneous Administration of Depo Provera® CI 150 mg/mL, Depo Provera® CI 300 mg/2 mL, or During Two Cycles of Depo-subQ Provera 104®
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- FHI 360
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Measure of time to ovulation
研究概览
简要总结
This is a randomized, multi-center, parallel-group Phase I study to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150 mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.
详细描述
This is a randomized, multi-center, parallel-group Phase I study with a primary objective to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150mg/mL or 300mg/2mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.
Secondary study objectives are:
- To evaluate and compare the pharmacokinetics (PK) of MPA after a single SC injection of 150mg/mL or 300mg/2mL of Depo-Provera CI to two injections of Depo-subQ 104 administered 3 months apart
- To evaluate the relationship between serum MPA concentration and suppression of ovulation
- To evaluate and compare the safety, tolerability and acceptability of a SC injection of DMPA of different frequencies, doses and volumes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DMPA 150
single subcutaneous injection of 150mg/mL of DMPA in the abdomen
干预措施: DMPA 150 (Drug)
DMPA 300
single subcutaneous injection of 300mg/2mL of DMPA in the abdomen
干预措施: DMPA 300 (Drug)
DMPA 104
two injections, given at three months intervals, of 104mg/0.65mL of DMPA in the abdomen
干预措施: DMPA 104 (Drug)
结局指标
主要结局
Measure of time to ovulation
时间窗: up to 18 months
次要结局
- Product acceptability(up to 18 months)
- Terminal elimination half-life (t1/2)(up to 18 months)
- Cmax(up to 18 months)
- Pulse at follow up(up to 18 months)
- Aggregate of individual C182 measurements and parameters(18 months after injection)
- Aggregate of individual C210 measurements and parameters(18 months after injection)
- Type and frequency of adverse events(up to 18 months)
- Aggregate of individual Tmax measurements and parameters(Up to 18 months)
- Aggregate of individual C91 measurements and parameters(18 months after injection)
- Measure of delayed return to ovulation(up to 18 months)
- Weight at follow up(up to 18 months)
- MPA concentration at Day 91 (C91)(91 days after injection)
- MPA concentration at Day 182 (C182)(182 days after injection)
- Area under the curve (AUC 0-182)(182 days after injection)
- Aggregate of individual Cmax measurements and parameters(up to 18 months)
- Blood pressure at follow up(up to 18 months)
- Number of participants with Injection site reactions(up to 18 months)
- Serum concentrations of cortisol(7.5 months)
- Tmax(up to 18 months)
- MPA concentration at Day 210 (C210)(210 days after injection)