drugset / Trial / NCT01295294

Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)

NCT01295294

Phase 4 Completed 187 enrolled Bayer
RandomizedSingle-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2011-03
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Mefenamic acid Small molecule 500 mg Oral
Subject Tranexamic Acid Small molecule 500 mg Oral
Background Levonorgestrel Small molecule 20 ug Other

Indications