Clinical trial NCT01295294: Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uterine Hemorrhage
Keywords: Uterine Hemorrhage
Contraception
Contraceptive Methods
Intrauterine devices
Mirena
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-02-14
Enrollment: 187
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The primary efficacy variable will be the cumulative number of bleeding / spotting days
timeFrame: During 90 day double-blind treatment period
Secondary outcomes:
measure: To describe and compare the bleeding patterns observed in women during treatment period
timeFrame: 90 day treatment period
measure: To describe and compare the bleeding patterns observed in women during follow-up period
timeFrame: During the 30 day follow-up period
measure: Satisfaction with oral blinded study drug treatment for bleeding / spotting
timeFrame: 90 day treatment period
measure: Occurrence of dysmenorrhea
timeFrame: During 120 day study period
measure: Continuation rate with study drug
timeFrame: During the 90 day treatment period
measure: Continuation rate with Mirena
timeFrame: During 120 day study period
measure: Adverse Events Collection
timeFrame: Until day 120
measure: Number of spotting-only days
timeFrame: During the 90-day treatment period
measure: Number of bleeding / spotting episodes
timeFrame: During the 90-day treatment period
measure: Length of bleeding / spotting episodes
timeFrame: During the 90-day treatment period
measure: Number of bleeding days with heavy intensity
timeFrame: During the 90-day treatment period
measure: Change in the number of B/S days between Day 60 and Day 90 of MIRENA use and the 30-day follow-up period
timeFrame: Up to day 120
measure: Satisfaction with levonorgestrel-releasing intrauterine system
timeFrame: Up to day 120
measure: Number of days of pain medication for dysmenorrhea during the 90 day treatment period
timeFrame: During the 90-day treatment period
measure: Number of bleeding-only days
timeFrame: During the 90-day treatment period
Other outcomes:
Locations:
city: København NV
country: Denmark
city: Odense C
country: Denmark
city: Skive
country: Denmark
city: Søborg
country: Denmark
city: Ålborg
country: Denmark
city: Århus C
country: Denmark
city: Mallow
country: Ireland
state: Cork
city: Blackrock
country: Ireland
state: Dublin
city: Cork
country: Ireland
city: Elverum
country: Norway
city: Haugesund
country: Norway
city: Trondheim
country: Norway
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.