Prospective, Open-label, Single-center Clinical Study to Investigate the Red Blood Cell and Plasma Folate Concentrations During a 24-week Treatment Period With the Combination of Drospirenone 3 mg Plus Ethinyl Estradiol 0.02 mg Plus Levomefolate Calcium 0.451 mg in Mexican Women Seeking Contraception
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 34
- 主要终点
- Change in RBC folate concentration from baseline to Week 24
研究概览
简要总结
The objective of this study is to compare the red blood cell (RBC) and plasma concentrations of folate in subjects treated with drospirenone (DRSP)/ethinyl estradiol (EE) plus levomefolate calcium (L-5-MTHF) at 24 weeks with respect to basal determination.
Increased intake of folic acid (synthetic form of the naturally occurring B-vitamin) before and in the first few weeks of pregnancy has been shown to reduce certain types of birth defects. This is important for women who may become pregnant following discontinuation of oral contraception. Information about any side effects that may occur will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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, Mexican female subjects requesting contraception
- •Age >/=18 to </=45 years (inclusive); smokers must not be older than 30 years at the time of informed consent
- •Normal or clinically insignificant cervical smear not requiring further follow-up; a cervical smear has to be taken at the screening visit, or a normal result has to be documented within the previous 6 months. Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.
排除标准
- •Pregnancy or lactation (less than 6 months since delivery, abortion, or lactation before start of treatment)
- •Body mass index (BMI) >30 kg/m2
- •Hypersensitivity to any ingredient in the study drug
- •Any diseases or conditions that can compromise the function of body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
- •Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- •Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
- •Undiagnosed abnormal genital bleeding
- •Abuse of alcohol, drugs or medicine (eg, laxatives)
- •Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug
研究组 & 干预措施
EE20/DRSP/L-5-MTHF
干预措施: EE20/DRSP/L-5-MTHF (Beyaz, BAY98-7071) (Drug)
结局指标
主要结局
Change in RBC folate concentration from baseline to Week 24
时间窗: Baseline and Week 24
Change in plasma folate concentration from baseline to Week 24
时间窗: Baseline and Week 24
次要结局
- Plasma folate concentration(Different time points up to 32 weeks)
- RBC folate concentration(Different time points up to 32 weeks)