Trial Condition(s):

Uterine Hemorrhage

Management of initial bleeding/spotting associated with the levonorgestrel-releasing intrauterine system (MIRENA)

Bayer Identifier:

15105

ClinicalTrials.gov Identifier:

NCT01295294

EudraCT Number:

2010-020922-16

Study Completed

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.

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

Trial Summary

Enrollment Goal
187
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
Yes
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Specialistlægesellskabet John Dræby ApS

Odense C, Denmark, DK-5000

Status
Completed
 
Locations

Speciallæge Anette Peen

Århus C, Denmark, DK-8000

Status
Completed
 
Locations

Dr Mary Short

Blackrock, Ireland

Status
Completed
 
Locations

The Practrice

Mallow, Ireland

Status
Completed
 
Locations

Langford Hall Medical Centre

Cork, Ireland

Status
Completed
 
Locations

Speciallæge Lise Helmsøe-Zinck

Søborg, Denmark, DK-2860

Status
Completed
 
Locations

Klinik for kvindesygdomme & graviditet

Skive, Denmark, DK-7800

Status
Completed
 
Locations

Speciallæge Morten Ring

Ålborg, Denmark, DK-9000

Status
Completed
 
Locations

Speciallæge Claus Christoffersen

København NV, Denmark, DK-2400

Status
Completed
 
Locations

Medicus AS

Trondheim, Norway, 7012

Status
Completed
 
Locations

Kvinnelegen i Hedmark

Elverum, Norway, 2403

Status
Completed
 
Locations

Haugesund Gyn Klinikk AS

Haugesund, Norway, 5507

Status
Completed
 

Trial Design