A Bioequivalence Study to Evaluate the Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- NGMN plasma concentrations (Periods 1 and 2)
研究概览
简要总结
The purpose of this study is to assess the bioequivalence of the contraceptive hormones of ORTHO EVRA when the patch is applied with and without an adhesive overlay.
详细描述
This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), single-center, single-application, 2-way crossover study (participants receive different interventions sequentially during the trial) of ORTHO EVRA with and without an adhesive overlay. ORTHO EVRA is a combination transdermal (through the skin) contraceptive patch containing 6.00 mg of the progestin norelgestromin (NGMN) and 0.75 mg of the estrogen, ethinyl estradiol (EE). The participants will be randomly assigned to 1 of 2 possible treatment sequences to ensure that they receive both of the following treatments, 1 in each period: - Treatment A: ORTHO EVRA patch applied to the buttock with an adhesive overlay applied over the transdermal contraceptive system; - Treatment B: ORTHO EVRA patch applied to the buttock without an overlay. The study consists of a screening phase; an open-label treatment phase consisting of 2 single-application 7-day treatment periods; and end-of-study or withdrawal assessments done upon completion of the 240-hour pharmacokinetic sampling on Day 11 of Period 2 or upon withdrawal. Pharmacokinetic evaluations explore how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. The two treatment periods will be separated by a washout period (period when receiving no treatment) of 21 days. During the study, safety and tolerability will also be assessed. The total duration of participation in the study for an individual will be approximately 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Signed informed consent
- •Body mass index (BMI) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg and not more than 90 kg
- •Must be surgically sterile with intact ovaries, abstinent, or, if sexually active, be practicing an effective method of non-hormonal birth control (eg, non-hormonal intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study
- •Completed her last term pregnancy at least 90 days before admission to the study site
- •History of regular menstrual cycles (occurring every 25 to 35 days)
- •Must not be pregnant or lactating
- •Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90 mmHg diastolic
- •Hemoglobin equal or more than 12.0 at screening
排除标准
- •History of smoking or use of nicotine-containing substances
- •Used steroid hormonal therapy within 30 days before admission to the study
- •Received a Depo Provera® injection in the 6 months before admission to the study
- •History or presence of disorders commonly accepted as contraindications to sex hormonal therapy
- •History of or current clinically significant medical illness or any other condition that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results
结局指标
主要结局
NGMN plasma concentrations (Periods 1 and 2)
时间窗: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
EE plasma concentrations (Periods 1 and 2)
时间窗: At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.
次要结局
- Pharmacokinetic parameters of NGMN (Periods 1 and 2)(At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.)
- Pharmacokinetic parameters of EE (Periods 1 and 2)(At 0, 24, 48, 72, 120, 168, 171, 174, 180, 192, 204, 216, and 240 hours.)
- Incidence of adverse events as a measure of safety and tolerability(Approximately 2 months)
- The number of patients with changes in clinical laboratory test values, physical examination results, and vital signs measurements(Approximately 2 months)