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

November 2, 2014 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • København NV, Denmark, DK-2400
      • Odense C, Denmark, DK-5000
      • Skive, Denmark, DK-7800
      • Søborg, Denmark, DK-2860
      • Ålborg, Denmark, DK-9000
      • Århus C, Denmark, DK-8000
  • Ireland
      • Cork, Ireland
    • Cork
      • Mallow, Cork, Ireland
    • Dublin
      • Blackrock, Dublin, Ireland
  • Norway
      • Elverum, Norway, 2403
      • Haugesund, Norway, 5507
      • Trondheim, Norway, 7012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Signed and dated informed consent
  • Healthy female subjects requesting contraception
  • Age: 18 - 45 years inclusive
  • Successful interval insertion of MIRENA
  • History of regular cyclic menstrual periods
  • Normal or clinically insignificant cervical smear not requiring further follow up

Exclusion Criteria:

  • Pregnancy or lactation
  • Climacteric symptoms prior to the screening visit
  • Known or suspected clinically significant ovarian cysts, endometrial polyps, fibroids, or other genital organ pathology, that, in the opinion of the investigator, may interfere with the assessment of the bleeding profile during the study
  • Undiagnosed abnormal genital bleeding
  • Current or history of thrombembolic disease, or established risk factors for venous thromboembolism
  • Current migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, or exceptionally severe headaches
  • Hypersensitivity to any ingredient of the investigational medicinal products or the non-investigational medicinal product
  • Daily or frequent use of a nonsteroidal anti-inflammatory drug (NSAIDs) for any condition
  • Not willing to use nonsteroidal anti-inflammatory drug (NSAIDs) medication as pain medication during the double blind treatment period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)
Subjects with successful MIRENA insertion will receive treatments with tranexamic acid
Drug: Tranexamic acid
500 mg 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
Experimental: mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)
Subjects with successful MIRENA insertion will receive treatments with mefenamic acid
Drug: Mirena (Levonorgestrel IUS, BAY86-5028)
In vitro release rate 20 microgram/24 hours. Intrauterine system
Drug: Mefenamic acid
500 mg 3 times daily per oral during bleeding/spotting episodes
Placebo Comparator: placebo + Mirena (Levonorgestrel IUS, BAY86-5028)
Subjects with successful MIRENA insertion will receive placebo
Drug: Mirena (Levonorgestrel IUS, BAY86-5028)
In vitro release rate 20 microgram/24 hours. Intrauterine system
Drug: Placebo
3 times daily per oral during bleeding/spotting episodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy variable will be the cumulative number of bleeding / spotting days
Time Frame: During 90 day double-blind treatment period
During 90 day double-blind treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe and compare the bleeding patterns observed in women during treatment period
Time Frame: 90 day treatment period
90 day treatment period
To describe and compare the bleeding patterns observed in women during follow-up period
Time Frame: During the 30 day follow-up period
During the 30 day follow-up period
Satisfaction with oral blinded study drug treatment for bleeding / spotting
Time Frame: 90 day treatment period
90 day treatment period
Occurrence of dysmenorrhea
Time Frame: During 120 day study period
During 120 day study period
Continuation rate with study drug
Time Frame: During the 90 day treatment period
During the 90 day treatment period
Continuation rate with Mirena
Time Frame: During 120 day study period
During 120 day study period
Adverse Events Collection
Time Frame: Until day 120
Until day 120
Number of spotting-only days
Time Frame: During the 90-day treatment period
During the 90-day treatment period
Number of bleeding / spotting episodes
Time Frame: During the 90-day treatment period
During the 90-day treatment period
Length of bleeding / spotting episodes
Time Frame: During the 90-day treatment period
During the 90-day treatment period
Number of bleeding days with heavy intensity
Time Frame: During the 90-day treatment period
During the 90-day treatment period
Change in the number of B/S days between Day 60 and Day 90 of MIRENA use and the 30-day follow-up period
Time Frame: Up to day 120
Up to day 120
Satisfaction with levonorgestrel-releasing intrauterine system
Time Frame: Up to day 120
Up to day 120
Number of days of pain medication for dysmenorrhea during the 90 day treatment period
Time Frame: During the 90-day treatment period
During the 90-day treatment period
Number of bleeding-only days
Time Frame: During the 90-day treatment period
During the 90-day treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 11, 2011

First Posted (Estimate)

February 14, 2011

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 2, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15105
  • 2010-020922-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Hemorrhage

Clinical Trials on Tranexamic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe