ACTRN12617000778381已完成未知
Study assessing the safety and tolerability of an intravaginal ointment containing oleic acid in healthy female volunteers.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Female
入选标准
- •Healthy non-pregnant females
- •Aged between 18 and 55
- •A normal atypical or low grade intraepithelial lesion on cervical smear in the preceding 12 months
- •BMI between 19 and 30 inclusive
- •Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
- •Able to provide written informed consent and willing to adhere to all study instructions and restrictions.
排除标准
- •Concomitant drug therapy for any condition that is not well controlled or that might affect the vaginal mucosa.
- •Sensitivity to the study ointment
- •History of any clinically significant medical conditions
- •Clinically significant abnormality or abnormal laboratory test result found during medical screening
- •Females who are pregnant and/or are breastfeeding
- •History of alcohol or drug abuse or dependency
- •Participation in a drug study within 30 days of the start of the study
- •Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
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