At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 165 enrolled
Drug / intervention
Levonorgestrel IUS (Mirena, BAY86-5028) +1 moredrug
Likely dose
Levonorgestrel IUS (Mirena, BAY86-5028) 20µgfrom 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.
A Multicenter, Randomized, Open Label, Parallel Group, Active Control Study to Evaluate the Efficacy and Safety of LNG IUS (Mirena®) as Compared to Medroxyprogesterone Acetate During 6 Cycles of Treatment in Patients With Idiopathic Menorrhagia
In Brief
A Phase 3 clinical trial evaluating Levonorgestrel IUS (Mirena, BAY86-5028) and Medroxyprogesterone acetate for Menorrhagia. Completed, enrolled 165 participants across 54 sites in 5 countries.
Detailed Summary
The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenorrhagia
CountriesArgentina, Brazil, Canada, Mexico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedAug 2006
Primary CompletionJun 2008
TodayJul 2026
First PostedAug 4, 2006
Enrollment StartJul 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.9 years ago
Interventions
Levonorgestrel IUS (Mirena, BAY86-5028)drug
Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
Medroxyprogesterone acetatedrug
Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.