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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01295294
First received: February 11, 2011
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  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.


Condition Intervention Phase
Uterine Hemorrhage
 Drug: Tranexamic acid
Drug: Mefenamic acid
Drug: Placebo
Drug: Mirena (Levonorgestrel IUS, BAY86-5028)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • The primary efficacy variable will be the cumulative number of bleeding / spotting days [ Time Frame: During 90 day double-blind treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe and compare the bleeding patterns observed in women during treatment period [ Time Frame: 90 day treatment period ] [ Designated as safety issue: No ]
  • To describe and compare the bleeding patterns observed in women during follow-up period [ Time Frame: During the 30 day follow-up period ] [ Designated as safety issue: No ]
  • Satisfaction with oral blinded study drug treatment for bleeding / spotting [ Time Frame: 90 day treatment period ] [ Designated as safety issue: No ]
  • Occurrence of dysmenorrhea [ Time Frame: During 120 day study period ] [ Designated as safety issue: No ]
  • Continuation rate with study drug [ Time Frame: During the 90 day treatment period ] [ Designated as safety issue: No ]
  • Continuation rate with Mirena [ Time Frame: During 120 day study period ] [ Designated as safety issue: No ]
  • Adverse Events Collection [ Time Frame: Until day 120 ] [ Designated as safety issue: Yes ]
  • Number of spotting-only days [ Time Frame: During the 90-day treatment period ] [ Designated as safety issue: No ]
  • Number of bleeding / spotting episodes [ Time Frame: During the 90-day treatment period ] [ Designated as safety issue: No ]
  • Length of bleeding / spotting episodes [ Time Frame: During the 90-day treatment period ] [ Designated as safety issue: No ]
  • Number of bleeding days with heavy intensity [ Time Frame: During the 90-day treatment period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Satisfaction with levonorgestrel-releasing intrauterine system [ Time Frame: Up to day 120 ] [ Designated as safety issue: No ]
  • Number of days of pain medication for dysmenorrhea during the 90 day treatment period [ Time Frame: During the 90-day treatment period ] [ Designated as safety issue: No ]
  • Number of bleeding-only days [ Time Frame: During the 90-day treatment period ] [ Designated as safety issue: No ]

Enrollment: 187
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Mefenamic 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
Placebo Comparator: placebo + Mirena (Levonorgestrel IUS, BAY86-5028)
Subjects with successful MIRENA insertion will receive placebo
 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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295294

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
Mallow, Cork, Ireland
Blackrock, Dublin, Ireland
Cork, Ireland
Norway
Elverum, Norway, 2403
Haugesund, Norway, 5507
Trondheim, Norway, 7012
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT01295294     History of Changes
Other Study ID Numbers: 15105, 2010-020922-16
Study First Received: February 11, 2011
Last Updated: April 8, 2013
Health Authority: Denmark: The Ministry of the Interior and Health
Ireland: Irish Medicines Board
Norway: Norwegian Medicines Agency
Turkey: Ministry of Health

Keywords provided by Bayer:
Uterine Hemorrhage
Contraception
Contraceptive Methods
Intrauterine devices
Mirena

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Levonorgestrel
Mefenamic Acid
Tranexamic Acid
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
 Contraceptives, Oral
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics

ClinicalTrials.gov processed this record on June 18, 2013