Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)

Multi-center, Open, Randomized, Dose Finding Phase II Study to Investigate Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) Releasing Different Amounts of Levonorgestrel Compared to MIRENA in Nulliparous and Parous Women in Need of Contraception.

The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Although the title of the study describes "open", it was in fact single-blinded.

Issues on side effects are addressed in the Adverse Event section.

Inclusion Criteria:

• Women with or without children and good general health and in need of contraception.
• Regular menstrual cycle without hormonal contraceptives.

Exclusion Criteria:

• Pregnant or lactating.
• Last delivery or abortion less than 12 weeks ago.
• Previous pregnancies outside the womb.
• Previous pelvic infections.
• Abnormal bleeding.
• Abnormal uterine cavity.
• Climacteric signs.
• Genital cancer.
• Liver diseases.
• Alcoholism or drug abuse.