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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Contraceptive Agents; Levonorgestrel

Criteria

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.