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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
187
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
Unnamed facility
Aalborg, Denmark
Unnamed facility
Århus C, Denmark
Unnamed facility
København NV, Denmark
Unnamed facility
Odense C, Denmark
The primary efficacy variable will be the cumulative number of bleeding / spotting days
Time frame: During 90 day double-blind treatment period
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
In vitro release rate 20 microgram/24 hours. Intrauterine system
Unnamed facility
Skive, Denmark
Unnamed facility
Søborg, Denmark
Unnamed facility
Mallow, Cork, Ireland
Unnamed facility
Blackrock, Dublin, Ireland
Unnamed facility
Cork, Ireland
Unnamed facility
Elverum, Norway
...and 2 more locations
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