An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)

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)

This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception.

The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.

Inclusion Criteria:

• Healthy female subjects in need for contraception will be selected to participate in the trial;
• Each subject must be >=18 to <=40 years of age at screening and in need for contraception;
• Each subject must have given birth to at least one child (gestational age >=28 weeks);
• 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.

Exclusion Criteria:

• A subject must not be pregnant or suspected to be pregnant;
• 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;
• A subject must not have a history or presence of any malignancy;
• A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies;
• A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism);
• A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of >=3 times the upper normal limit;
• A subject must not have congenital or acquired malformations or distortions of the uterus or cervix;
• 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;
• A subject must not have vaginal bleeding of undiagnosed etiology;
• A subject must not have dysmenorrhea interfering with daily activities or menorrhagia