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

NCT01295294 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2014-11-04

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Denmark
  • Ireland
  • Norway

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01295294 on ClinicalTrials.gov