EUCTR2009-012121-11-DE进行中（未招募）不适用
A randomized, multicenter, explorative trial to explore the safety, acceptability and vaginal bleeding pattern of three doses of an etonogestrel-releasing medicated intrauterine system (ENG-MIUS) versus a copper-releasing intrauterine device (IUD) (Phase 2; Protocol No. P06060 (299001))
Schering-Plough Research Institute, a Division of Schering Corporation0 个研究点目标入组 80 人开始时间: 2009年8月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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. Each subject must be 18 up to and including 40 years of age at screening and in need of contraception;
- •2. Each subject must have given birth to at least one child (gestational age = 28 weeks);
- •3. Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri.
- •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. A subject must not be pregnant or suspected to be pregnant;
- •2. A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis;
- •3. A subject must not have any malignancy at screening and must not have a history of a sex-steroid sensitive malignancy eg, of the genital organs or the breast;
- •4. A subject must not have a premalignant disease of the uterus or cervix, including endometrial hyperplasia and cervical dysplasia, or (other) sex-steroid sensitive premalignancies;
- •5. A subject must not have an active venous thromboembolic disorder (eg, deep vein thrombosis, pulmonary embolism);
- •6. A subject must not have a history or presence of severe hepatic disease with aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels of = three times the upper normal limit;
- •7. A subject must not have congenital or acquired malformations or distortions of the uterus or cervix;
- •8. A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator;
- •9. A subject must not have vaginal bleeding of undiagnosed etiology;
- •10. A subject must not have dysmenorrhea interfering with daily activities or menorrhagia;
- •11. A subject must not have an abnormal cervical smear at screening, defined as Bethesda (2001) = low grade squamous intraepithelial lesion (LSIL) or cervical intraepithelial neoplasia (CIN) = CIN 1;
- •12. A subject must not have a genital infection at MIUS/IUD insertion;
- •13. A subject must not have active pelvic inflammatory disease (PID) at screening or must not have a history of recurrent PID (defined as twice a year);
- •14. A subject must not have chlamydia, gonorrhea, or human immunodeficiency virus (HIV) at screening or must not have had these diseases within 12 months prior to screening;
- •15. A subject must not have a history of complete or partial expulsion with another IUD/IUS;
- •16. A subject must not have had an infected abortion within three months prior to screening;
- •17. A subject must not have had an abortion or delivery within six weeks or a caesarean section within three months prior to screening, and must not have an incomplete uterine involution after abortion or postpartum.
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