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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Uterine Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Subjects with successful MIRENA insertion will receive treatments with tranexamic acid

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

500 mg 3 times daily per oral during bleeding/spotting episodes

Mirena (Levonorgestrel IUS, BAY86-5028)

Intervention Type DRUG

In vitro release rate 20 microgram/24 hours. Intrauterine system

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

Subjects with successful MIRENA insertion will receive treatments with mefenamic acid

Group Type EXPERIMENTAL

Mefenamic acid

Intervention Type DRUG

500 mg 3 times daily per oral during bleeding/spotting episodes

Mirena (Levonorgestrel IUS, BAY86-5028)

Intervention Type DRUG

In vitro release rate 20 microgram/24 hours. Intrauterine system

placebo + Mirena (Levonorgestrel IUS, BAY86-5028)

Subjects with successful MIRENA insertion will receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

3 times daily per oral during bleeding/spotting episodes

Mirena (Levonorgestrel IUS, BAY86-5028)

Intervention Type DRUG

In vitro release rate 20 microgram/24 hours. Intrauterine system

Interventions

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Tranexamic acid

500 mg 3 times daily per oral during bleeding/spotting episodes

Intervention Type DRUG

Mefenamic acid

500 mg 3 times daily per oral during bleeding/spotting episodes

Intervention Type DRUG

Placebo

3 times daily per oral during bleeding/spotting episodes

Intervention Type DRUG

Mirena (Levonorgestrel IUS, BAY86-5028)

In vitro release rate 20 microgram/24 hours. Intrauterine system

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes