At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 364 enrolled
Drug / intervention
Levonorgestrel IUS (Mirena, BAY86-5028)drug
Likely dose
Levonorgestrel IUS (Mirena, BAY86-5028) 20 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center, Open-label, Uncontrolled Study to Assess Contraceptive Efficacy and Safety of Mirena During Extended Use Beyond 5 Years in Women 18 to 35 Years of Age Including a Subgroup Evaluation of Treatment Effect on Heavy Menstrual Bleeding
In Brief
A Phase 3 clinical trial evaluating Levonorgestrel IUS (Mirena, BAY86-5028) for Contraception. Completed, enrolled 364 participants across 49 sites.
Detailed Summary
The study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding \[HMB\]) and safety will be assessed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartDec 2016
Primary CompletionMay 2021
TodayJul 2026
First PostedDec 7, 2016
Enrollment StartDec 22, 2016
Primary CompletionMay 28, 2021
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 9.6 years ago
Interventions
Levonorgestrel IUS (Mirena, BAY86-5028)drug
Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day.