Multi-Center, Randomized, Double-Blind Active-Controlled, Parallel Group Study to Investigate Plasma Folate, Red Blood Cell Folate and Homocysteine Levels During a 24 Week Oral Administration of an OC Containing Folate Compared to OC Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 385
- 试验地点
- 9
- 主要终点
- Red Blood Cell (RBC) Folate Level at 24 Weeks
研究概览
简要总结
The purpose of this study is to determine whether the study drug is safe and effective
详细描述
Acronym is used in result section: suspected/diagnosed (susp/diag)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women between 18 and 40 requesting oral contraception
排除标准
- •The use of steroidal oral contraceptives, or any drug that could alter Oral Contraception metabolism will be prohibited during the study
研究组 & 干预措施
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)
1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
干预措施: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate (Drug)
Drospirenone (DRSP)/Ethinylestradiol (EE)
1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
干预措施: Drospirenone/Ethinylestradiol (Yaz) (Drug)
结局指标
主要结局
Red Blood Cell (RBC) Folate Level at 24 Weeks
时间窗: Week 24
RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit
Plasma Folate Level at 24 Weeks
时间窗: Week 24
Folate concentrations in plasma were determined by an appropriately validated microbiological assay.
次要结局
- Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12(baseline and up to week 12)
- Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16(baseline and up to week 16)
- Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20(baseline and up to week 20)
- Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4(baseline and up to week 4)
- Mean Change From Baseline in Plasma Folate Levels at Week 8(baseline and up to week 8)
- Mean Neural Tube Defect (NTD) Risk Reduction at Week 24(Baseline and week 24)
- Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8(baseline and up to week 8)
- Mean Change From Baseline in Plasma Folate Levels at Week 4(baseline and up to week 4)
- Mean Change From Baseline in Plasma Folate Levels at Week 12(baseline and up to week 12)
- Mean Change From Baseline in Plasma Folate Levels at Week 16(baseline and up to week 16)
- Mean Change From Baseline in Plasma Folate Levels at Week 20(baseline and up to week 20)
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 4(baseline and up to week 4)
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 8(baseline and up to week 8)
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 12(baseline and up to week 12)
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 16(baseline and up to week 16)
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 20(baseline and up to week 20)
- Mean Change From Baseline in Plasma Homocysteine Levels at Week 24(baseline and up to week 24)