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

Phase 4

Completed

• Conditions: Uterine Hemorrhage
• Interventions: Drug: Tranexamic acid; Drug: Placebo; Drug: Mefenamic acid; Drug: Mirena (Levonorgestrel IUS, BAY86-5028)

• Registration Number: NCT01295294
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-11
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Study Start: 2011-03
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-02
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 187

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)	Tranexamic acid	Subjects with successful MIRENA insertion will receive treatments with tranexamic acid
tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)	Mirena (Levonorgestrel IUS, BAY86-5028)	Subjects with successful MIRENA insertion will receive treatments with tranexamic acid
placebo + Mirena (Levonorgestrel IUS, BAY86-5028)	Placebo	Subjects with successful MIRENA insertion will receive placebo
mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)	Mirena (Levonorgestrel IUS, BAY86-5028)	Subjects with successful MIRENA insertion will receive treatments with mefenamic acid
placebo + Mirena (Levonorgestrel IUS, BAY86-5028)	Mirena (Levonorgestrel IUS, BAY86-5028)	Subjects with successful MIRENA insertion will receive placebo
mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)	Mefenamic acid	Subjects with successful MIRENA insertion will receive treatments with mefenamic acid

Primary Outcome Measures

Name	Time	Method
The primary efficacy variable will be the cumulative number of bleeding / spotting days	During 90 day double-blind treatment period

Secondary Outcome Measures

Name	Time	Method
Number of bleeding days with heavy intensity	During the 90-day treatment period
Change in the number of B/S days between Day 60 and Day 90 of MIRENA use and the 30-day follow-up period	Up to day 120
Satisfaction with levonorgestrel-releasing intrauterine system	Up to day 120
Number of days of pain medication for dysmenorrhea during the 90 day treatment period	During the 90-day treatment period
Number of bleeding-only days	During the 90-day treatment period
To describe and compare the bleeding patterns observed in women during treatment period	90 day treatment period
To describe and compare the bleeding patterns observed in women during follow-up period	During the 30 day follow-up period
Satisfaction with oral blinded study drug treatment for bleeding / spotting	90 day treatment period
Occurrence of dysmenorrhea	During 120 day study period
Continuation rate with study drug	During the 90 day treatment period
Continuation rate with Mirena	During 120 day study period
Adverse Events Collection	Until day 120
Number of spotting-only days	During the 90-day treatment period
Number of bleeding / spotting episodes	During the 90-day treatment period
Length of bleeding / spotting episodes	During the 90-day treatment period