JPRN-jRCT2080223983已完成2 期
Phase II study to evaluate pharmacodynamics, pharmacokinetics and safety after cyclic dose or continuous dose of FSN-013 for 3 cycles in Japanese healthy adult female subjects
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 34age old（—）
- 性别
- Female
入选标准
- •(1) Japanese Healthy adult female subjects (subjects who were judged to be healthy by investigators)
- •(2) 20 or older and younger than 35 years old
- •(3) Subjects whose weights were 40 kg or more and BMIs were18.5 or more and less than 25.0 at screening examinations
- •(4) Subjects who ovulated between Day9(+/-1) and Day 27(+/-1) of their menstruations in pretreatment observation period and whose progesterone concentrations after that were 5 ng/mL or more and menorrhea didn't start before second registration.
- •(5) Subjects whose both ovaries can be observed by transvaginal ultrasound examinations.
排除标准
- •(1) Subjects whose menstrual cycles were beyond range of 25 to 38 days regularly
- •(2) Subjects whose spontaneous menorrhea were not observed previously after dosing hormonal products for contraception
- •(3) Subjects in whom unknown cause of abnormal bleedings were observed within past 6 months or their reoccurences were expected during tiral period
- •(4) Subjects whose cervix cytodiagnoses were abnormal previously
研究者
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