Overview

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

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bayer
Treatments:
Levonorgestrel
Mefenamic Acid
Tranexamic Acid
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