NCT01140217已完成3 期
An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System
Watson Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 1,659 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,659
- 试验地点
- 1
- 主要终点
- Pregnancy Rate
研究概览
简要总结
The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.
详细描述
An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System.
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 females
- •18-45 years
- •Regular, consistent menstrual cycles between 25 and 35 days
- •Sexually active and at risk of becoming pregnant
排除标准
- •History of infertility
- •Known contraindications to progestogen administration
- •Pap smear suggestive of a high-grade precancerous lesion(s)
- •Clinically significant deviation from normal in any of the screening tests or exams
研究组 & 干预措施
Active treatment
Experimental
Norethindrone Acetate Transdermal Delivery System
干预措施: Norethindrone Acetate (Drug)
结局指标
主要结局
Pregnancy Rate
时间窗: 1 year
The pregnancy rate will be calculated using the Pearl Index that defined as 1300\*Number of pregnancies/Number of cycles of treatment.
次要结局
未报告次要终点
研究者
研究点 (1)
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