The Pharmacokinetics of 12 Week Continuous Patch Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
研究概览
简要总结
Investigators propose a descriptive pharmacokinetic study of the serum hormone levels of estrogen and progesterone with extended use (12 weeks) of the contraceptive patch. The primary objective is to assess the change in serum ethinyl estradiol (EE2) levels over 12 weeks of continuous contraceptive patch use. The secondary objective is assessing the the norelgestromin (NGMN) levels over the 12 weeks of continuous contraceptive patch use.
详细描述
For women who are seeking alternatives to long-acting contraceptives, the oral contraceptive pill and the contraceptive ring are often prescribed in an extended manner (12 weeks straight). The contraceptive patch, however, is not routinely prescribed in this way. Concerns have been raised that hormone levels, in particular estrogen, are higher among patch users than those who use oral contraception or the vaginal ring and that this may contribute to an increased risk of clot. However, few studies have actually looked at these hormone levels in women with extended use of the contraceptive patch.
The investigators plan to enroll eligible women age 18-39 who are willing to use the contraceptive patch continuously for twelve weeks, and can adhere to the study requirements for follow-up. All participants will have weekly serum assessments of ethinyl estradiol and norelgestromin levels. The investigators will enroll 30 women, in anticipation of a 33% attrition rate, with the goal of obtaining completed data on 20 participants. The study duration for an individual participant will be 12 weeks and the duration of the entire study will be one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing and able to come to the clinic to have blood drawn weekly for 12 weeks, biweekly during weeks 4, 8, and 12, and for 3 days after the final patch is removed for blood draws for a total of 18 blood draws
- •Willing and able to abstain from using any other hormonal contraceptive method while in the study and for the week prior to starting the study
排除标准
- •Body Mass Index greater than 35
- •Personal or Family History of Venothromboembolism
- •Personal History of Migraines with Aura
- •Personal History of Migraines without Aura
- •Tobacco use greater than or equal to 15 cigarettes per day
- •Current Pregnancy
- •History of or Current Diagnosis of Cancer
研究组 & 干预措施
Xulane
All participants using the Xulane contraceptive patch for 12 continuous weeks
干预措施: Xulane Contraceptive Patch (Device)
结局指标
主要结局
Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use
时间窗: Total of 18 blood draws - once at the end of each patch week and two times during weeks four, eight and twelve (with the additional blood draw occurring mid-week); and blood draws performed for three continuous days after the final patch was removed
Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2
次要结局
- NGMN Levels Over 12 Weeks of Continuous Patch Use(12 weeks)
研究者
Antonella Lavelanet
Physician
Boston Medical Center