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)
- Conditions
- contraceptiecontraception
- Registration Number
- NL-OMON32765
- Lead Sponsor
- Schering-Plough
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and acceptability</p><br>
- Secondary Outcome Measures
Name Time Method <p>Vaginal bleeding pattern<br /><br>Ovarian function<br /><br>Cervical mucus and endometrial thickness<br /><br>Contraceptive efficacy<br /><br><br /><br>For subgroup:<br /><br>ENG serum pharmacokinetics</p><br>