Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - PK and PD of 30mg and 60mg UPA
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of Participants With Delay in Follicular Rupture Beyond 5 Days
研究概览
简要总结
Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency contraception containing ulipristal acetate. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but this protocol registration is for the UPA aspect of the study procedures.
详细描述
Emergency contraception (EC) provides a woman with an additional line of defense against unintended pregnancy following an act of unprotected intercourse. Orally-dosed EC works by delaying ovulation and reduces the risk of pregnancy for a single act of unprotected intercourse by 50-70%. Unfortunately, obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed EC and in some instances EC is equivalent to placebo.
Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed EC in obese women. We hypothesize that increasing the dose of orally-dosed EC agents will normalize the pharmacokinetics resulting in the expected treatment effect (delay in follicle rupture) in obese women. In the overall proposal, we plan to perform detailed pharmacokinetic and pharmacodynamic studies of UPA-based EC in obese women and expand upon our preliminary findings of LNG-based EC. This protocol registration is for the UPA aspect of the study procedures focused on the pharmacokinetics and pharmacodynamics of UPA and will include a dose escalation intervention.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Generally healthy women
- •Aged 18-35 years old
- •Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3 ng/mL or greater
- •Subjects must have a BMI of >30kg/m2 and weight at least 80kg or more OR a BMI <25kg/m2 and a weight of less than 80kg.
排除标准
- •Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
- •Impaired liver or renal function
- •Actively seeking or involved in a weight loss program (must be weight stable) pregnancy, breastfeeding, or seeking pregnancy
- •Recent (within last 8 weeks) use of hormonal contraception
- •Current use of drugs that interfere with metabolism of sex steroids
研究组 & 干预措施
UPA-ECx1 followed by ECx2
Ulipristal acetate 30mg orally x 1 dose, washout cycle and then in the next menstrual cycle, 60mg x 1 dose. Timing of dosage depends on follicle measurements.
干预措施: UPA-ECx1 (Drug)
UPA-ECx1 followed by ECx2
Ulipristal acetate 30mg orally x 1 dose, washout cycle and then in the next menstrual cycle, 60mg x 1 dose. Timing of dosage depends on follicle measurements.
干预措施: UPA-ECx2 (Drug)
UPA-ECx2 followed by ECx1
Ulipristal acetate 60mg orally x 1 dose, washout cycle, and then in next menstrual cycle 30mg orally x 1 dose. Timing of dosage depends on follicle measurements.
干预措施: UPA-ECx1 (Drug)
UPA-ECx2 followed by ECx1
Ulipristal acetate 60mg orally x 1 dose, washout cycle, and then in next menstrual cycle 30mg orally x 1 dose. Timing of dosage depends on follicle measurements.
干预措施: UPA-ECx2 (Drug)
UPA-ECx1 Normal BMI/weight
Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group.
干预措施: UPA-ECx1 (Drug)
结局指标
主要结局
Number of Participants With Delay in Follicular Rupture Beyond 5 Days
时间窗: 1 menstrual cycle, assessed up to 38 days
Follicular rupture (yes/no) beyond 5 days from EC dosing by ultrasound in participants with a BMI \>/=30 kg/m2. The comparison is between menstrual cycles where 30 versus 60 mg of UPA was taken. Follicular rupture is defined as the disappearance of or \>50% reduction in size of the leading follicle. The day of EC dosing is defined as day zero.
次要结局
- Maximum Serum Concentration of Ulipristal Acetate(24 hours)
研究者
Alison Edelman
Professor, OB/GYN
Oregon Health and Science University