NCT00551616已完成3 期
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception
HRA Pharma24 个研究点 分布在 3 个国家目标入组 2,221 人开始时间: 2007年4月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,221
- 试验地点
- 24
- 主要终点
- Number of Participants With Pregnancy
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US
- •present within 120 hours of unprotected intercourse
- •regular menstrual cycles
- •No current use of hormonal contraception
- •Willing to not use hormonal methods of contraception until study completion
- •At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion
- •For women who present more than 72 hours after intercourse, decline the insertion of an Intra Uterine Device for emergency contraception
- •Able to provide informed consent
- •Willing to abstain from further acts of unprotected intercourse until study completion
排除标准
- •One or more acts of unprotected intercourse more than 120 hours
- •current or recent use of hormonal methods of contraception
- •currently pregnant or breastfeeding
- •tubal ligation or current use of IUD
- •Use of hormonal emergency contraception since last menstrual period
- •Current use of IUD
- •Tubal ligation
- •Partner with a vasectomy
- •Unsure about the date of the last menstrual period
- •Severe asthma insufficiently controlled by oral glucocorticoid
- •Hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study
研究组 & 干预措施
CDB-2914
Experimental
干预措施: CDB-2914 (Drug)
Levonorgestrel
Active Comparator
干预措施: Levonorgestrel (Drug)
结局指标
主要结局
Number of Participants With Pregnancy
时间窗: Within 72 hours of unprotected Intercourse
The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.
次要结局
- Menstrual Bleeding Patterns(within the menstrual cycle of the unprotected Intercourse)
- Actual Pregnancy Rate Compared to Expected Pregnancy Rate(Within 120 hours of unprotected Intercourse)
研究者
研究点 (24)
Loading locations...
相似试验
已完成
2 期
Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) SurgeContraceptionNCT01107093HRA Pharma35
已完成
3 期
Safety and Efficacy of CDB-2914 for Emergency ContraceptionEmergency ContraceptionNCT00411684HRA Pharma1,623
已完成
1 期
Comparison of Blood Levels of Two Formulations of the Selective Hormone Receptor Modulator CDB-2914HealthyNCT00041899Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)15
已完成
3 期
Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)Reactive Airways Disease (RAD)NCT00685126Sumitomo Pharma America, Inc.117
Unknown
不适用
Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot UlcersDiabetic Foot UlcerNCT03110796Laboratoires URGO210