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.
2 other identifiers
interventional
187
3 countries
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2011
Shorter than P25 for phase_4
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedNovember 4, 2014
November 1, 2014
9 months
February 11, 2011
November 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy variable will be the cumulative number of bleeding / spotting days
During 90 day double-blind treatment period
Secondary Outcomes (15)
To describe and compare the bleeding patterns observed in women during treatment period
90 day treatment period
To describe and compare the bleeding patterns observed in women during follow-up period
During the 30 day follow-up period
Satisfaction with oral blinded study drug treatment for bleeding / spotting
90 day treatment period
Occurrence of dysmenorrhea
During 120 day study period
Continuation rate with study drug
During the 90 day treatment period
- +10 more secondary outcomes
Study Arms (3)
tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)
EXPERIMENTALSubjects with successful MIRENA insertion will receive treatments with tranexamic acid
mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)
EXPERIMENTALSubjects with successful MIRENA insertion will receive treatments with mefenamic acid
placebo + Mirena (Levonorgestrel IUS, BAY86-5028)
PLACEBO COMPARATORSubjects with successful MIRENA insertion will receive placebo
Interventions
500 mg 3 times daily per oral during bleeding/spotting episodes
500 mg 3 times daily per oral during bleeding/spotting episodes
3 times daily per oral during bleeding/spotting episodes
In vitro release rate 20 microgram/24 hours. Intrauterine system
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (12)
Unknown Facility
Aalborg, DK-9000, Denmark
Unknown Facility
Århus C, DK-8000, Denmark
Unknown Facility
København NV, DK-2400, Denmark
Unknown Facility
Odense C, DK-5000, Denmark
Unknown Facility
Skive, DK-7800, Denmark
Unknown Facility
Søborg, DK-2860, Denmark
Unknown Facility
Mallow, Cork, Ireland
Unknown Facility
Blackrock, Dublin, Ireland
Unknown Facility
Cork, Ireland
Unknown Facility
Elverum, 2403, Norway
Unknown Facility
Haugesund, 5507, Norway
Unknown Facility
Trondheim, 7012, Norway
Related Publications (1)
Sordal T, Inki P, Draeby J, O'Flynn M, Schmelter T. Management of initial bleeding or spotting after levonorgestrel-releasing intrauterine system placement: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):934-941. doi: 10.1097/AOG.0b013e31828c65d8.
PMID: 23635728DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2011
First Posted
February 14, 2011
Study Start
March 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
November 4, 2014
Record last verified: 2014-11