Pharmacokinetics of Levonorgestrel and Ulipristal Acetate Emergency Contraception in Women With Normal and Obese Body Mass Index
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration
研究概览
简要总结
A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The investigators propose a study to compare serum LNG and UPA levels after administration of a single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no difference in PK parameters between women with normal BMI and obese women.
详细描述
Eligible women will present to the division research office, at which time a history and physical exam will be completed. Each participant's BMI will be confirmed and she will be assigned to one of two BMI groups (18.5-24.9 versus 30-39.9). At the conclusion of the enrollment visit, the research coordinator will randomize each woman to receive a single-dose pill of either levonorgestrel 1.5mg (like Plan B One-Step® or its generic formulations) or ulipristal acetate 30mg (ellaOne®) on two separate occasions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Women aged 18-45 years
- •English-speaking
- •BMI 18.5-24.9 kg/m2 or obese BMI 30.0-39.9 kg/m2
- •Regular menstrual cycles
- •No use of medroxyprogesterone acetate at least 6 months prior to study enrollment, unless resumption of two menstrual cycles
- •No use of levonorgestrel intrauterine system (levonorgestrel-IUS), etonogestrel implant or combined hormonal contraception at least one month prior to the study and resumption of one menstrual cycle
- •Women who are postpartum or post-abortion will be included if they have had at least one menstrual cycle since their last pregnancy
排除标准
- •Prior allergic reaction to LNG-EC or UPA-EC
- •Use of hormonal emergency contraception within the past month
- •Women who are currently pregnant or who are currently breastfeeding
- •History of cancer other than non-melanoma skin cancer
- •Medical or surgical conditions or conditions requiring therapies known to impact sex steroid production or metabolism
- •Use of HAART therapy for management of HIV infection
- •Concomitant use of CYP3A4 inducers like rifampin, barbiturates, carbamazepine, lamotrigine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St. John's Wort and topiramate
- •Current participation in any other trial of an investigational medicine or device in the three months leading up to this study
研究组 & 干预措施
Normal-BMI
Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
干预措施: LNG-EC (Drug)
Normal-BMI
Women with normal BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
干预措施: UPA-EC (Drug)
Obese-BMI
Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
干预措施: LNG-EC (Drug)
Obese-BMI
Women with obese BMI will receive the first emergency contraception (EC) dose and complete pharmacokinetics (PK) assessments; then return to the clinic after at least 8 days to receive the second study drug and complete the same assessments. The study drugs Levonorgestrel (LNG-EC) and Ulipristal Acetate (UPA-EC) will be given in random order.
干预措施: UPA-EC (Drug)
结局指标
主要结局
Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration
时间窗: Up to 24 hours
UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.
Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration
时间窗: Up to 24 hours
LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.
次要结局
- Elimination Half-life of Serum UPA(Up to 24 hours)
- Maximum Concentration of Serum UPA(Up to 24 hours)
- Clearance of Serum UPA(Up to 24 hours)
- Maximum Concentration of Serum LNG(Up to 24 hours)
- Time to Maximum Concentration of Serum LNG(Up to 24 hours)
- Time to Maximum Concentration of Serum UPA(Up to 24 hours)
- Elimination Half-life of Serum LNG(Up to 24 hours)
- Clearance of Serum LNG(Up to 24 hours)
研究者
Carolyn L. Westhoff
Director, Division of Family Planning and Preventive Services
Columbia University