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) - ENG-MIUS

Schering-Plough0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Healthy female subjects in need for contraception.
•Age at least 18-40 years at screening.
•Subjects must have given birth to at least one child (gestational age >= 28 weeks).

•Exclusion criteria are mainly base on the approved labeling for Multiload® and Implanon®. ;• 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
•a sex-steroid sensitive malignancy
•active venous thromboembolic disorder
•severe hepatic disease in the past
•premalignant disease of the uterus or cervix, a.o. lsrge or multiple uterine fibromyomata
•vaginal bleeding of undiagnosed etiology severe, dysmenorrhea or menorrhagia
•an abnormal cervical smear
•a genital infection
•active pelvic inflammatory disease (PID) at screening or must not have a history of recurrent PID (defined as twice a year)
•chlamydia, gonorrhea, or human immunodeficiency virus (HIV) at screening or within 12 months prior to screening
•a history of complete or partial expulsion with another IUD/IUS in the history
•an infected abortion within three months prior to screening, an abortion or delivery within six weeks or a caesarean section within three months prior to screening, incomplete uterine involution after abortion or postpartum

发起方

Schering-Plough