check_circleStudy Completed

Uterine Hemorrhage

Bayer Identifier:

15105

ClinicalTrials.gov Identifier:

NCT01295294

EudraCT Number:

2010-020922-16

EU CT Number:

Not Available
Management of initial bleeding/spotting associated with the levonorgestrel-releasing intrauterine system (MIRENA)

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - 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


  • - 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

Trial summary

Enrollment Goal
187
Trial Dates
March 2011 - December 2011
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Specialistlægesellskabet John Dræby ApSOdense C, DK-5000, Denmark
Completed
Speciallæge Anette PeenÅrhus C, DK-8000, Denmark
Completed
Dr Mary ShortBlackrock, Ireland
Completed
The PractriceMallow, Ireland
Completed
Langford Hall Medical CentreCork, Ireland
Completed
Speciallæge Lise Helmsøe-ZinckSøborg, DK-2860, Denmark
Completed
Klinik for kvindesygdomme & graviditetSkive, DK-7800, Denmark
Completed
Speciallæge Morten RingÅlborg, DK-9000, Denmark
Completed
Speciallæge Claus ChristoffersenKøbenhavn NV, DK-2400, Denmark
Completed
Medicus ASTrondheim, 7012, Norway
Completed
Kvinnelegen i HedmarkElverum, 2403, Norway
Completed
Haugesund Gyn Klinikk ASHaugesund, 5507, Norway

Primary Outcome

  • The primary efficacy variable will be the cumulative number of bleeding / spotting days
    date_rangeTime Frame:
    During 90 day double-blind treatment period
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

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

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Single Group Assignment
Trial Arms
3

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