Emergency Contraception and Body Weight: Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel
研究概览
简要总结
The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.
详细描述
To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free LNG serum concentrations.
We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Subjects are between the ages of 18 and 35
- •Subjects are in good general health
- •Subjects have regular menstrual cycles (between 21 and 35 days)
- •Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD).
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 (8 week) use of hormonal contraception
- •Current use of drugs that interfere with metabolism of sex steroids
研究组 & 干预措施
Normal BMI ECx1
5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG
干预措施: ECx1 (Drug)
Obese BMI ECx1
5 obese women (BMI >30 kg/m2) taking 1.5mg LNG
干预措施: ECx1 (Drug)
Obese BMI ECx2
5 obese women (BMI >30 kg/m2) taking 3mg LNG
干预措施: ECx2 (Drug)
结局指标
主要结局
Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel
时间窗: Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel
次要结局
- Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel(Follicular phase of menstrual cycle)
研究者
Alison Edelman
Associate Professor
Oregon Health and Science University