NCT01615354已完成1 期
Single-Center, Randomized, Double-Blind, Placebo Controlled, Crossover Study to Assess the Effect of Aleglitazar on the Pharmacokinetics and Pharmacodynamics of Ethinyl Estradiol and Levonorgestrel as Components of the Oral Contraceptive Microgynon®
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Pharmacokinetics of Levonorgestrel: area under the concentration time curve
研究概览
简要总结
This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the other period volunteers will receive placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
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
- •Healthy female volunteer, 18 to 45 years of age
- •Body mass index (BMI) between 18.0 and 29.9 kg/m2
- •Body weight at least 55.0 kg
- •Non-pregnant, not lactating and not planning pregnancy from screening to 3 months after the last dose of study treatment
- •Non-smoker for at least 3 months
排除标准
- •Currently active gynecological disorder
- •History of amenorrhea within the previous 3 years
- •Known or suspected history of estrogen-dependent neoplasia or sex hormone-dependent malignant tumors
- •Use of steroid hormone-containing intrauterine device (IUD) or progesterone-release IUD contraceptive within 3 months to screening.
- •History of clinically significant disease that could jeopardize the volunteer safety in the study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Microgynon® (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Treatment
Experimental
干预措施: Aleglitazar (Drug)
Treatment
Experimental
干预措施: Microgynon® (Drug)
结局指标
主要结局
Pharmacokinetics of Levonorgestrel: area under the concentration time curve
时间窗: pre-dose and up to 24 hours post-dose
Pharmacokinetics of ethinyl estradiol: area under the concentration time curve
时间窗: pre-dose and up to 24 hours post-dose
次要结局
- Pharmacodynamics: luteinizing/follicular stimulation hormone concentration(Days 1, 7, 13, 14, 15, 21)
- Safety: incidence of adverse events(16 weeks)
研究者
相似试验
已完成
3 期
Efficacy and Safety Study of GB-0998 for Treatment of Systemic SclerosisScleroderma, SystemicNCT00348296Benesis Corporation60
已完成
3 期
Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.Erectile DysfunctionNCT01305083Abdi Ibrahim Ilac San. ve Tic A.S.118
已完成
2 期
A Comparison of Continuous Bevacizumab (Avastin) Treatment or Placebo in Addition to Lomustine Followed by Standard of Care After Disease Progression in Participants With GlioblastomaGlioblastomaNCT01860638Hoffmann-La Roche296
已完成
1 期
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy VolunteersHealthy VolunteerNCT01461967Hoffmann-La Roche49
终止
2 期
Study of RO6807952 in Patients With Diabetes Mellitus Type 2Diabetes Mellitus Type 2NCT01516476Hoffmann-La Roche2