EUCTR2014-004612-10-Outside-EU/EEA进行中（未招募）不适用
A multicenter, double-blind, randomized, placebo controlled study to evaluate the efficacy and safety of an oral contraceptive preparation YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) for 6 treatment cycles in women with moderate acne
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 172
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Inclusion Criteria: - Women of age 14-45 years - >1 year post-menarche with moderate acne vulgaris who have no known contraindications to combined oral contraceptives - Otherwise healthy, except for the presence of moderate acne - Smokers up to a maximum age of 30 (inclusive) at inclusion
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 172
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 86
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria: - Pregnancy, lactation (less than three menstrual cycles since delivery, abortion, or lactation before start of treatment) - Obesity (Body Mass Index > 30 kg/m2) - Hypersensitivity to any ingredient of the study drug - Any disease or condition that may worsen under hormonal treatment
研究者
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