A Prospective, Randomized, Double Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerance of CDB-2914 With Levonorgestrel as Emergency Contraception
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,672
- 试验地点
- 7
- 主要终点
- Pregnancy (efficacy)
研究概览
简要总结
Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception
Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception
Subjects are randomized to receive a one-time treatment with either one dose of 50 mg CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)
The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.
详细描述
Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception
Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception
Duration: A one-time treatment with either CDB-2914 or levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)
Treatment: A one-time treatment with one of the following:
- Two doses of 0.75 mg of levonorgestrel to be taken 12 hours apart
- One dose of 50 mg CDB-2914 and a second placebo dose to be taken 12 hours later
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Menstruating women at least 18 years old;
- •Give voluntary, written informed consent, and agree to observe all study requirements;
- •Request emergency contraception within 72 hours (3 days) after unprotected coitus, as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure;
- •Reports that all acts of unprotected coitus during the current cycle are within 72 hours prior to enrollment;
- •Willing to abstain from further acts of unprotected intercourse during that cycle;
- •History of regular menstrual cycles (mean length of 24-42 days with intra-individual variation of ±5 days);
- •At least one normal menstrual cycle (2 menses) post delivery or abortion;
- •If subject recently discontinued hormonal contraception, one normal menstrual cycle (2 menses) must have been completed before entry in the study
- •For women with a recent history of Depo Provera use, the most recent injection must be at least 3 months before study entry and the subject must have had at least one normal menstrual cycle (2 menses);
- •Available for follow-up for at least the next four weeks.
排除标准
- •Currently pregnant (positive high-sensitivity urine pregnancy test);
- •pregnant or breast-feeding within the past two months;
- •use of hormonal methods of contraception during the current or previous two cycles;
- •current user of IUD;
- •tubal ligation;
- •partners with history of vasectomy;
- •unsure about the date of the last menstrual period (+3 days);
- •irregular menstrual cycles as defined in the inclusion criteria;
- •nausea and vomiting within the previous two weeks;
- •impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year.
- •Subjects cannot be currently enrolled in any other investigational trial or re-enrolled in this study.
结局指标
主要结局
Pregnancy (efficacy)
时间窗: until follow-up about one week after next menses
次要结局
- Tolerability (side effects)(until follow-up about one week after next menses)
- Menstrual cycle effects(until follow-up about one week after next menses)