NCT01595022已完成1 期
A Multi-center, Single-blinded, Randomized, Controlled, Parallel-group Study to Evaluate the Wearing Comfort of Two Different Placebo Intrauterine Systems FR01 and FR20 Compared to a Placebo T-frame Intrauterine System for 3 Cycles in Healthy Women Aged 18-40 Years
Bayer10 个研究点 分布在 3 个国家目标入组 90 人开始时间: 2010年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 10
- 主要终点
- Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain)
研究概览
简要总结
The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Female subject
- •Age 18-40 years (inclusive)
- •History of regular cyclic menstrual periods at baseline (cycle length 21 to 35 days)
- •Women using any COC (combined oral contraceptive) for contraception with a monthly regimen before the study entry.
- •Confirmed uterine sound depth of 6 to 10 cm
排除标准
- •Pregnancy or lactation
- •Sterilized
- •Nulliparous
- •Congenital or acquired uterine anomaly
- •Vaginal or cesarean delivery within 8 weeks prior to insertion
研究组 & 干预措施
Flexi ring FR01
Placebo Comparator
干预措施: Placebo: Flexi ring FR01 (Drug)
Flexi ring FR20
Placebo Comparator
干预措施: Placebo: Flexi ring FR20 (Drug)
Ultra low dose LCS
Placebo Comparator
干预措施: Placebo: Ultra low dose levonorgestrel contraceptive system (LCS) (Drug)
结局指标
主要结局
Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain)
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (10)
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