At a glance
ClinicalIndex Comparison Record- ✓Women with or without children in good general health and needing contraception
- ✓Regular menstrual cycle without current hormonal contraceptive use
- ✕Pregnant or lactating
- ✕Last delivery or abortion less than 12 weeks ago
- ✕History of ectopic pregnancy (pregnancy outside the womb)
- ✕History of pelvic infections
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating Levonorgestrel IUS (BAY86-5028, G04209B), Levonorgestrel IUS (BAY86-5028, G04209C), and 1 other intervention for Contraception. Completed, enrolled 742 participants across 35 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years
Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years
Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years