check_circleStudy Completed
Uterine Hemorrhage
Bayer Identifier:
15105
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Management of initial bleeding/spotting associated with the levonorgestrel-releasing intrauterine system (MIRENA)
Trial purpose
The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena. The study drugs tested are tested against placebo (“dummy medication not containing any active drug”). Treatment period is followed by a one-month period when study drugs are not taken but Mirena use is continued.
Key Participants Requirements
Sex
FemaleAge
18 - 45 YearsTrial summary
Enrollment Goal
187Trial Dates
March 2011 - December 2011Phase
Phase 4Could I Receive a placebo
YesProducts
Mirena (Levonorgestrel IUS, BAY86-5028)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Specialistlægesellskabet John Dræby ApS | Odense C, DK-5000, Denmark |
Completed | Speciallæge Anette Peen | Århus C, DK-8000, Denmark |
Completed | Dr Mary Short | Blackrock, Ireland |
Completed | The Practrice | Mallow, Ireland |
Completed | Langford Hall Medical Centre | Cork, Ireland |
Completed | Speciallæge Lise Helmsøe-Zinck | Søborg, DK-2860, Denmark |
Completed | Klinik for kvindesygdomme & graviditet | Skive, DK-7800, Denmark |
Completed | Speciallæge Morten Ring | Ålborg, DK-9000, Denmark |
Completed | Speciallæge Claus Christoffersen | København NV, DK-2400, Denmark |
Completed | Medicus AS | Trondheim, 7012, Norway |
Completed | Kvinnelegen i Hedmark | Elverum, 2403, Norway |
Completed | Haugesund Gyn Klinikk AS | Haugesund, 5507, Norway |
Primary Outcome
- The primary efficacy variable will be the cumulative number of bleeding / spotting daysdate_rangeTime Frame:During 90 day double-blind treatment periodenhanced_encryptionNoSafety Issue:
Secondary Outcome
- To describe and compare the bleeding patterns observed in women during treatment perioddate_rangeTime Frame:90 day treatment periodenhanced_encryptionNoSafety Issue:
- To describe and compare the bleeding patterns observed in women during follow-up perioddate_rangeTime Frame:During the 30 day follow-up periodenhanced_encryptionNoSafety Issue:
- Satisfaction with oral blinded study drug treatment for bleeding / spottingdate_rangeTime Frame:90 day treatment periodenhanced_encryptionNoSafety Issue:
- Occurrence of dysmenorrheadate_rangeTime Frame:During 120 day study periodenhanced_encryptionNoSafety Issue:
- Continuation rate with study drugdate_rangeTime Frame:During the 90 day treatment periodenhanced_encryptionNoSafety Issue:
- Continuation rate with Mirenadate_rangeTime Frame:During 120 day study periodenhanced_encryptionNoSafety Issue:
- Adverse Events Collectiondate_rangeTime Frame:Until day 120enhanced_encryptionYesSafety Issue:
- Number of spotting-only daysdate_rangeTime Frame:During the 90-day treatment periodenhanced_encryptionNoSafety Issue:
- Number of bleeding / spotting episodesdate_rangeTime Frame:During the 90-day treatment periodenhanced_encryptionNoSafety Issue:
- Length of bleeding / spotting episodesdate_rangeTime Frame:During the 90-day treatment periodenhanced_encryptionNoSafety Issue:
- Number of bleeding days with heavy intensitydate_rangeTime Frame:During the 90-day treatment periodenhanced_encryptionNoSafety Issue:
- Change in the number of B/S days between Day 60 and Day 90 of MIRENA use and the 30-day follow-up perioddate_rangeTime Frame:Up to day 120enhanced_encryptionNoSafety Issue:
- Satisfaction with levonorgestrel-releasing intrauterine systemdate_rangeTime Frame:Up to day 120enhanced_encryptionNoSafety Issue:
- Number of days of pain medication for dysmenorrhea during the 90 day treatment perioddate_rangeTime Frame:During the 90-day treatment periodenhanced_encryptionNoSafety Issue:
- Number of bleeding-only daysdate_rangeTime Frame:During the 90-day treatment periodenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Single Group AssignmentTrial Arms
3Additional Information
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