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

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