Pharmacogenomics of Contraception: Genetic Variants and Etonogestrel Pharmacokinetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Genome wide genotyping results
研究概览
简要总结
The proposed study will investigate the relationship between genetic variants and serum contraceptive hormone levels, specifically the progestin etonogestrel. This study will provide the foundation for future pharmacogenomic investigations of more commonly used contraceptive methods with higher failure rates.
详细描述
Approximately 700 reproductive age women (18-45) with an Etonogestrel (ENG) contraceptive implant in place for more than 1 year will be enrolled. Participants will undergo a blood draw for measurement of ENG concentration (serum) and genotyping (whole blood) and complete a questionnaire regarding their demographics and contraceptive, gynecological, and obstetrical history. The research investigators will also consent participants for use of their genetic samples and clinical data in future unspecified research.
The serum samples will be de-identified for ENG analysis, which will be done using a liquid chromatography-mass spectrometry method. Additional whole blood samples collected at the enrollment visit will undergo DNA extraction. A candidate gene study was conducted using the first 350 participants. The research investigators selected 120 genetic variants for 14 target genes involved in progestin metabolism, regulation, and function for this candidate gene study. A Genome Wide Association Study will be performed using all 700 participants. Genotyping will be performed using a custom MultiEthnic Global Array chip through the Colorado Center for Personalized Medicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •women of reproductive age (18-45 years)
- •have had an ENG contraceptive implant in place for 12-36 months
排除标准
- •Use of medications or supplements in the past four weeks which could impact serum ENG levels through inhibition or induction of CYP enzymes (specifically CYP-3A4)
- •Medical conditions that could impact baseline liver function (e.g. hepatitis, cirrhosis)
- •Body mass index (BMI) less than 18.5
结局指标
主要结局
Genome wide genotyping results
时间窗: DNA extracted from whole blood specimens will be genotyped at the conclusion of enrollment, approximately 15 months.
Participants will undergo genotyping using a custom MEGA chip at the Colorado Center for Personalized Medicine. Imputation of the chip results will be performed.
Proportion of genetic variants in cases versus controls
时间窗: DNA extracted from whole blood specimens will be genotyped at the conclusion of enrollment, approximately 12 months.
Genetic variants will be analyzed using a Taqman microarray chip for 120 pre-selected variants
次要结局
未报告次要终点