NCT02104609已完成不适用
Pharmacokinetics of the Levonorgestrel-only Emergency Contraception Regimen in Normal-weight, Obese and Extremely Obese Users: a Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Maximum concentration (Cmax)
研究概览
简要总结
The purpose of this study is to determine the effects of obesity on the pharmacokinetics of the levonorgestrel (LNG) only emergency contraceptive (EC) regimen and on markers of ovulation
Primary hypothesis:
- Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger volume of distribution of LNG.
Secondary hypothesis:
- Alterations in these pharmacokinetic parameters of the LNG-EC regimen in obese women affect the primary mechanism of action, which is inhibition of ovulation.
- Obesity may affect other factors that alter levels of LNG, such as sex-hormone binding globulin (SHBG) and albumin, which bind LNG and potentially lowers the amount of free LNG.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between ages 18-35 years
- •Regular menstrual cycles (24-35 days) for the past 2 months
- •Ovulatory at defined by midluteal progesterone level >3 ng/mL (Day 18-25)
- •Belongs to one of the following categories: normal weight (BMI = 18.5-24.9 kg/m2), obese (BMI = 30-39.9 kg/m2) or extremely obese (BMI ≥ 40 kg/m2)
- •Participant has no intention of or desire to conceive (e.g., active attempt to become pregnant or in vitro fertilization) for the duration of the study
- •Participant agrees to consistently use an effective method of nonhormonal contraception throughout the duration of study, which could include: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, non-hormonal intra-uterine devise (IUD), or sterilization.
- •Able to give informed consent
排除标准
- •• Known renal or liver disease
- •Known pituitary disorder
- •Known adrenal disorder
- •Known thyroid disorder
- •Use of medication known to alter the cytochrome P450 system
- •Use of depot-medroxyprogesterone acetate in the previous 6 months or any other hormonal contraceptive in the previous 3 months
- •Currently breastfeeding
- •Pregnancy in the prior month
- •Known allergy to medication
- •Other specific contraindications to LNG EC
研究组 & 干预措施
Normal weight women
Levonorgestrel 1.5mg by mouth once
干预措施: Levonorgestrel 1.5mg by mouth once (Drug)
Obese women
Levonorgestrel 1.5mg by mouth once
干预措施: Levonorgestrel 1.5mg by mouth once (Drug)
Extremely obese women
Levonorgestrel 1.5mg by mouth once
干预措施: Levonorgestrel 1.5mg by mouth once (Drug)
结局指标
主要结局
Maximum concentration (Cmax)
时间窗: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
次要结局
- Minimum concentration (Cmin)(Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours)
- Time to maximum concentration (Tmax)(0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours)
- Area under the concentration time-curve (AUC)(Time 0, 1, 2, 3, 4, 6, 8, 12, 6, 24, 48, 72 hrs)
研究者
Melissa Natavio
Asst. Professor
University of Southern California
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Pharmacologic Strategies to Use the Levonorgestrel Implant in HIV-infected WomenHIVContraceptionNCT02722421University of Nebraska28
已完成
不适用
Pharmacokinetics of Implanon in Obese WomenContraceptionObesityNCT00724438University of Chicago18
招募中
不适用
Obesity effect on the characteristics of the blood-thinning drug rivaroxabavenous thromboembolismobesityatrial fibrillationACTRN12622000297729Medical Research Center, Hamad Medical Corporation81
已完成
1 期
A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese SubjectsMorbid ObesityNCT01591148Stanford University30
已完成
4 期
A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese AdolescentsPediatric ObesityChildhood ObesityNCT02714062VIVUS LLC42