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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uterine Hemorrhage

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

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

Official title: International, Prospective, Double-blind, 3-arm Comparative, Randomized, Placebo-controlled Phase IV Study on the Effect of Counseling and Either Tranexamic Acid or Mefenamic Acid or Placebo, on the Management of Bleeding/Spotting in Women Using the Levonorgestrel-releasing Intrauterine System (MIRENA) for Contraception.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary efficacy variable will be the cumulative number of bleeding / spotting days

Secondary outcome:

To describe and compare the bleeding patterns observed in women during treatment period

To describe and compare the bleeding patterns observed in women during follow-up period

Satisfaction with oral blinded study drug treatment for bleeding / spotting

Occurrence of dysmenorrhea

Continuation rate with study drug

Continuation rate with Mirena

Adverse Events Collection

Number of spotting-only days

Number of bleeding / spotting episodes

Length of bleeding / spotting episodes

Number of bleeding days with heavy intensity

Change in the number of B/S days between Day 60 and Day 90 of MIRENA use and the 30-day follow-up period

Satisfaction with levonorgestrel-releasing intrauterine system

Number of days of pain medication for dysmenorrhea during the 90 day treatment period

Number of bleeding-only days

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

København NV DK-2400, Denmark

Odense C DK-5000, Denmark

Skive DK-7800, Denmark

Søborg DK-2860, Denmark

Ålborg DK-9000, Denmark

Århus C DK-8000, Denmark

Cork, Ireland

Elverum 2403, Norway

Haugesund 5507, Norway

Trondheim 7012, Norway

Mallow, Cork, Ireland

Blackrock, Dublin, Ireland

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here and search for websynopsis information of Bayer's products.

Click here and search for information of Bayer products for Europe

Starting date: March 2011
Last updated: November 2, 2014

Page last updated: August 23, 2015

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