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

Bayer

Status and phase: Completed; Phase 4

Conditions: Uterine Hemorrhage

Treatments: Drug: Placebo; Drug: Tranexamic acid; Drug: Mirena (Levonorgestrel IUS, BAY86-5028); Drug: Mefenamic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01295294

15105

2010-020922-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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187 participants in 3 patient groups, including a placebo group

tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)

Experimental group

Description:

Subjects with successful MIRENA insertion will receive treatments with tranexamic acid

Treatment:

Drug: Mirena (Levonorgestrel IUS, BAY86-5028)

Drug: Tranexamic acid

mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)

Experimental group

Description:

Subjects with successful MIRENA insertion will receive treatments with mefenamic acid

Treatment:

Drug: Mirena (Levonorgestrel IUS, BAY86-5028)

Drug: Mefenamic acid

placebo + Mirena (Levonorgestrel IUS, BAY86-5028)

Placebo Comparator group

Description:

Subjects with successful MIRENA insertion will receive placebo

Treatment:

Drug: Mirena (Levonorgestrel IUS, BAY86-5028)

Drug: Placebo