A Phase I Study to Assess Skin Irritation and Sensitization of HP-1050 Transdermal System Compared to XULANE in Healthy Adult Females
试验速览
- 阶段
- 1 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Skin Irritation Evaluation
研究概览
简要总结
A randomized, evaluator-blinded study to assess skin irritation and skin sensitization of HP-1050 transdermal system (HP-1050) in comparison to XULANE patch in healthy female volunteers.
详细描述
This is a dual-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of HP-1050 transdermal system in comparison to XULANE patch in healthy female volunteers. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy non-pregnant, non-lactating females 18-35 years of age (inclusive0 and who are candidates for hormonal contraception;
- •Subjects who have previously used hormonal contraceptives without complications or naïve subjects for whom hormonal contraceptives are not contraindicated in the opinion of the Principal Investigator;
- •Subjects who are willing to stop using any current contraceptives for the duration of the study;
排除标准
- •Subjects who are currently taking or have taken oral hormonal contraceptives within 30 days prior to the first patch application;
- •Subjects who are currently using any long-acting hormonal method of contraception or has used them within the past 3 months;
- •Subjects who have a contraindication for estrogen or norelgestromin, or subjects who have a history of sensitivity to estrogen or norelgestromin or any related derivatives;
研究组 & 干预措施
HP-1050 patch
HP-1050 and Xulane will be administered simultaneously.
干预措施: HP-1050 Patch (Drug)
结局指标
主要结局
Skin Irritation Evaluation
时间窗: 21 days
To evaluate skin irritation after exposure to HP-1050 compared to XULANE®
Sensitization Evaluation
时间窗: 48 hours
To evaluate skin sensitization after exposure to HP-1050 compared to XULANE®
次要结局
未报告次要终点