NCT01295294

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

International, Prospective, Double-blind, 3-arm Comparative, Randomized, Placebo-controlled Phase IV Study on the Effect of Counseling and Either Tranexamic Acid or Mefenamic Acid or Placebo, on the Management of Bleeding/Spotting in Women Using the Levonorgestrel-releasing Intrauterine System (MIRENA) for Contraception.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Uterine Hemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic acid	500 mg 3 times daily per oral during bleeding/spotting episodes
DRUG	Mefenamic acid	500 mg 3 times daily per oral during bleeding/spotting episodes
DRUG	Placebo	3 times daily per oral during bleeding/spotting episodes
DRUG	Mirena (Levonorgestrel IUS, BAY86-5028)	In vitro release rate 20 microgram/24 hours. Intrauterine system

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-02-14
• Last updated: 2014-11-04

Locations

12 sites across 3 countries: Denmark, Ireland, Norway