NCT00884260已完成3 期
Multi-center, Open Label, Single Arm Study to Assess Efficacy, Safety, Bleeding Pattern and Pharmacokinetics of the Ultra Low Dose Levonorgestrel Intrauterine Contraceptive System (LCS) for a Maximum of 3 Years in Women 18 to 40 Years of Age
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 918
- 主要终点
- Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.
- •Normal cervical smear (normal cervical smear within the last six months prior to visit 1 presented in writing can be accepted. The cervical smear should be analyzed and reported according to the Bethesda System.)
- •Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion).
- •Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).
排除标准
- •Known or suspected pregnancy or is lactating.
- •Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit
- •Note: Postpartum insertions should be postponed until uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation.
- •History of ectopic pregnancies. Note: For Korea only: History of ectopic pregnancies or high probability of ectopic gestation.
- •Infected abortion within 3 months prior to visit
- •Note: For Korea only: Endometritis after delivery or infected abortion within 3 months prior to visit
- •Abnormal uterine bleeding of unknown origin.
- •Any genital infection (until successfully treated).
- •History of, or current, pelvic inflammatory disease
- •Congenital or acquired uterine anomaly.
- •Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of the LCS.
- •History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.
- •Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.
- •Clinically significant endometrial polyp(s), which, in the opinion of the investigator, will interfere with the assessment of the bleeding profile during the study
- •Clinically significant ovarian cyst(s)
- •Use of any long-acting injectable sex-hormone preparations within 12 months prior to start of study medication, and if entering subset: any sex-hormone administration within one month prior to start of the study medication.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Levonorgestrel IUS (LCS, BAY86-5028) (Drug)
结局指标
主要结局
Primary efficacy variable is the occurrence of pregnancy, the Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
时间窗: 3 years
次要结局
- Adverse events(3 years)
- Discontinuation rates(3 years)
- Laboratory tests(3 years)
- LCS expulsion rate(3 years)
研究者
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