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

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ClinicalTrials.gov Identifier: NCT01295294
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE February 11, 2011
First Posted Date  ICMJE February 14, 2011
Last Update Posted Date November 4, 2014
Study Start Date  ICMJE March 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2011)
The primary efficacy variable will be the cumulative number of bleeding / spotting days [ Time Frame: During 90 day double-blind treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01295294 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2013)
  • To describe and compare the bleeding patterns observed in women during treatment period [ Time Frame: 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 ]
  • Satisfaction with oral blinded study drug treatment for bleeding / spotting [ Time Frame: 90 day treatment period ]
  • Occurrence of dysmenorrhea [ Time Frame: During 120 day study period ]
  • Continuation rate with study drug [ Time Frame: During the 90 day treatment period ]
  • Continuation rate with Mirena [ Time Frame: During 120 day study period ]
  • Adverse Events Collection [ Time Frame: Until day 120 ]
  • Number of spotting-only days [ Time Frame: During the 90-day treatment period ]
  • Number of bleeding / spotting episodes [ Time Frame: During the 90-day treatment period ]
  • Length of bleeding / spotting episodes [ Time Frame: During the 90-day treatment period ]
  • Number of bleeding days with heavy intensity [ Time Frame: 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 ]
  • Satisfaction with levonorgestrel-releasing intrauterine system [ Time Frame: 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 ]
  • Number of bleeding-only days [ Time Frame: During the 90-day treatment period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2011)
  • To describe and compare the bleeding patterns observed in women during treatment period [ Time Frame: 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 ]
  • Satisfaction with oral blinded study drug treatment for bleeding / spotting [ Time Frame: 90 day treatment period ]
  • Occurrence of dysmenorrhea [ Time Frame: During 120 day study period ]
  • Continuation rate with study drug [ Time Frame: During the 90 day treatment period ]
  • Continuation rate with Mirena [ Time Frame: During 120 day study period ]
  • Adverse Events Collection [ Time Frame: Until day 120 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Uterine Hemorrhage
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)
    Subjects with successful MIRENA insertion will receive treatments with tranexamic acid
    Interventions:
    • Drug: Tranexamic acid
    • Drug: Mirena (Levonorgestrel IUS, BAY86-5028)
  • Experimental: mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)
    Subjects with successful MIRENA insertion will receive treatments with mefenamic acid
    Interventions:
    • Drug: Mefenamic acid
    • Drug: Mirena (Levonorgestrel IUS, BAY86-5028)
  • Placebo Comparator: placebo + Mirena (Levonorgestrel IUS, BAY86-5028)
    Subjects with successful MIRENA insertion will receive placebo
    Interventions:
    • Drug: Placebo
    • Drug: Mirena (Levonorgestrel IUS, BAY86-5028)
Publications * Sørdal 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):934-41. doi: 10.1097/AOG.0b013e31828c65d8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2013)
187
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2011)
186
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Ireland,   Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01295294
Other Study ID Numbers  ICMJE 15105
2010-020922-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP