NCT02967055已完成不适用
The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Serum Etonogestrel (ENG) Level
研究概览
简要总结
This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.
详细描述
The Investigators will enroll only women with an etonogestrel contraceptive implant in place who are initiating isotretinoin therapy through their dermatologist. The Investigators will monitor the subjects serum etonogestrel concentration during isotretinoin therapy but no medications will be provided through this study. No medical devices will be inserted as part of this study either.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Have a secondary form of non-hormonal contraception or abstain during isotretinoin therapy and four weeks afterwards
- •Have at least two negative pregnancy tests at least 19 days apart prior to initiating isotretinoin therapy
- •Have normal baseline laboratory evaluation including liver function tests, basic metabolic panel, and complete blood count
- •Willing to abstain from taking any Vitamin A supplement during the study period
- •Have a Body Mass Index (BMI) >= 18.5
排除标准
- •Currently breastfeeding
- •Known contraindications to isotretinoin
- •Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors
结局指标
主要结局
Serum Etonogestrel (ENG) Level
时间窗: 9 weeks
ENG levels will be measured 9 weeks after of initiation of isotretinoin therapy.
次要结局
未报告次要终点
研究者
研究点 (1)
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