NCT00280657已完成3 期
Multicenter, Double-blind, Double-dummy, Randomized Parallel Group Study to Evaluate the Safety and Efficacy of SH D 00659 E for 6 Treatment Cycles in Female Patients With Acne Papulopustulosa in Comparison to SH D 00659 G and Placebo.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,326
- 主要终点
- Change in lesions
研究概览
简要总结
The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate facial papulopustular acne
排除标准
- •Contraindication against use of hormonal contraceptives
研究组 & 干预措施
Arm 1
Experimental
干预措施: Valette (Drug)
Arm 2
Active Comparator
干预措施: Diane (Drug)
Arm 3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in lesions
时间窗: 6 months
次要结局
- Parameters of safety and tolerability(6 months)
- ISGA(6 months)
研究者
相似试验
Unknown
3 期
Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral ContraceptionOral ContraceptiveNCT02021097Regenex Pharmaceutical, China1,008
已完成
3 期
Effect on Primary DysmenorrheaPrimary DysmenorrheaNCT00909857Bayer507
已完成
3 期
Effects of SH T00658ID on LibidoContraceptionLibidoNCT00764881Bayer217
已完成
3 期
Pearl Index Study With Low Dose Combined Oral ContraceptiveContraceptionNCT00220324Bayer840
撤回
3 期
Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)ContraceptionNCT01723579Organon and Co