EUCTR2007-000420-40-HU进行中（未招募）不适用
Multi-center, open-label, randomized study to assess the safety and contraceptive efficacy of two doses (in vitro 12 µg/24 h and 16 µg/24 h) of the ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) for a maximum of 3 years in women 18 to 35 years of age - LCS Pearl Index Study
Bayer Schering Pharma Oy0 个研究点目标入组 2,820 人开始时间: 2007年7月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,820
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Has signed informed consent.
- •2.Is of age between 18 and 35 years (inclusive), in good general health and requesting contraception.
- •3.Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.
- •4.Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion).
- •5.Is willing and able to attend the scheduled visits and to comply with the study procedures.
- •Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Known or suspected pregnancy or is lactating.
- •2.Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 1.
- •3.History of ectopic pregnancies.
- •4.Infected abortion or postpartum endometritis within 3 months prior to visit 1.
- •5.Abnormal uterine bleeding of unknown origin.
- •6.Any genital infection (until successfully treated).
- •7.Descriptive diagnoses of epithelial cell atypias (not benign atypias) or more serious disorder in cervical smear (according to the Bethesda System) at screening and not responding to treatment.
- •8.History of, or current, pelvic inflammatory disease.
- •9.Congenital or acquired uterine anomaly.
- •10.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.
- •11.History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.
- •12.Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.
- •13.Current endometrial polyp(s).
- •14.Ovarian cyst(s) with diameter > 3 cm.
- •15.Concomitant use of other sex-hormone containing preparations or intrauterine device.
- •16.Use of any long-acting injectable sex-hormone preparations within 12 months prior to start of study medication,
- •and if entering subset 2 or subset 3: any sex-hormone administration within one month prior to start of the study medication
- •17.If entering subset 2: any drug that might affect the blood coagulation (e.g., heparin, coumarin) within one month prior to start of the study medication
- •18.If entering subset 2: any known condition that might affect the blood coagulation.
- •19.Established immunodeficiency.
- •20.Any known hypersensitivity to the constituents of the LCS.
- •21.Diagnosed or suspected malignant or premalignant disease at the screening.
- •22.Arterial hypertension not responding to treatment, with systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg.
- •23.Current (or history of) severe hepatic diseases including benign or malignant tumors. There should be an interval of at least 3 months between the start of study treatment (i.e., LCS insertion) and the return of liver function values to normal.
- •24.History of chronic alcoholism, drug dependence or abuse, psychotic states or severe neurosis or any other condition that, by judgment of the investigator, might impair subject's ability to cooperate.
- •25.Known or suspected HIV infection or high risk for STD.
- •26.Any clinically significant condition or laboratory result that, in the opinion of the investigator, compromises subject’s safety, might interfere with the evaluations or prevents the completion of the study. Non-inclusion laboratory values will be flagged by the laboratory based on predefined ranges .
- •27.Participated in another clinical study or consumed another experimental drug within 1 month prior to visit 1.
- •28.Previous participation in this study.
- •A person with close affiliation with the investigational site; e.g., close relative of the investigator, dependent person, employee or student of the investigational site.
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