Validation of 24-hour Trough Concentration as a Surrogate for Intensive Pharmacokinetic Measurements for a Combined Oral Contraceptive Pill Containing Desogestrel
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Serum Etonogestrel Concentrations
研究概览
简要总结
This study aims to validate prior pharmacokinetic research with combined oral contraceptive pill users that supports utilizing a 24-hour trough concentration as an accurate proxy for the intensive pharmacokinetic parameter of area under the curve (gold standard pharmacokinetics). The original pharmacokinetic studies were performed with a levonorgestrel-containing oral contraceptive pill and we aim to duplicate those findings with a desogestrel-containing oral contraceptive pill.
详细描述
Enrolled participants will be started on a standard pack of desogestrel-containing oral contraceptive pills and undergo an intensive pharmacokinetic study visit on day 21 of the pill pack. This will entail 11 serial blood draws and a final blood draw the next day at 24 hours post-pill intake to measure and calculate a pharmacokinetic area under the curve for both the estrogen and progestin components of the pill. We will then correlate the 24-hour trough measurement to the area under the curve measures to determine the correlation of these measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females aged 18-45 years
- •Body-mass index ≥18.5kg/m2
- •Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study
- •Normal blood pressure measurement at screening (systolic <140mmHg, diastolic <90mmHg)
- •Negative urine pregnancy test at screening
排除标准
- •Currently taking any known CYP3A4 inducers/inhibitors
- •Medical conditions that affect liver function (e.g. hepatitis, cirrhosis)
- •Any contraindications to estrogen-containing contraception (based on any category 3 or 4 recommendations from the CDC MEC guidelines)
- •Use of an injectable contraceptive method within the last 6 months or current use of an ENG contraceptive implant
- •Childbirth within the last 6 months
- •Known allergy or insensitivity to combined oral contraceptive pills
研究组 & 干预措施
Overall Cohort
Combined oral contraceptive pill containing 0.15mg desogestrel and 0.03mg ethinyl estradiol for 21 days
干预措施: Desogestrel and Ethinyl Estradiol Tablets (Drug)
结局指标
主要结局
Serum Etonogestrel Concentrations
时间窗: 24 hours
12 serum measurements taken over the course of 24 hours Correlation coefficient calculated for area under the curve versus 24-hour trough measurement
Serum Ethinyl Estradiol Concentrations
时间窗: 24 hours
12 serum measurements taken over the course of 24 hours Correlation coefficient calculated for area under the curve to 24-hour trough measurements
次要结局
未报告次要终点