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

Primary Purpose

Uterine Hemorrhage

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Tranexamic acid

Mefenamic acid

Placebo

Mirena (Levonorgestrel IUS, BAY86-5028)

About this trial

This is an interventional treatment trial for Uterine Hemorrhage focused on measuring Uterine Hemorrhage, Contraception, Contraceptive Methods, Intrauterine devices, Mirena

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

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

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

placebo + Mirena (Levonorgestrel IUS, BAY86-5028)

Arm Description

Subjects with successful MIRENA insertion will receive treatments with tranexamic acid

Subjects with successful MIRENA insertion will receive treatments with mefenamic acid

Subjects with successful MIRENA insertion will receive placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01295294

First Posted

February 11, 2011

Last Updated

November 2, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01295294

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Hemorrhage

Keywords

Uterine Hemorrhage, Contraception, Contraceptive Methods, Intrauterine devices, Mirena

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

187 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Subjects with successful MIRENA insertion will receive treatments with tranexamic acid

Arm Title

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

Arm Type

Experimental

Arm Description

Subjects with successful MIRENA insertion will receive treatments with mefenamic acid

Arm Title

placebo + Mirena (Levonorgestrel IUS, BAY86-5028)

Arm Type

Placebo Comparator

Arm Description

Subjects with successful MIRENA insertion will receive placebo

Intervention Type

Drug

Intervention Name(s)

Tranexamic acid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Mefenamic acid

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

3 times daily per oral during bleeding/spotting episodes

Intervention Type

Drug

Intervention Name(s)

Mirena (Levonorgestrel IUS, BAY86-5028)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

During 90 day double-blind treatment period

Secondary Outcome Measure Information:

Title

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

Time Frame

90 day treatment period

Title

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

Time Frame

During the 30 day follow-up period

Title

Satisfaction with oral blinded study drug treatment for bleeding / spotting

Time Frame

90 day treatment period

Title

Occurrence of dysmenorrhea

Time Frame

During 120 day study period

Title

Continuation rate with study drug

Time Frame

During the 90 day treatment period

Title

Continuation rate with Mirena

Time Frame

During 120 day study period

Title

Adverse Events Collection

Time Frame

Until day 120

Title

Number of spotting-only days

Time Frame

During the 90-day treatment period

Title

Number of bleeding / spotting episodes

Time Frame

During the 90-day treatment period

Title

Length of bleeding / spotting episodes

Time Frame

During the 90-day treatment period

Title

Number of bleeding days with heavy intensity

Time Frame

During the 90-day treatment period

Title

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

Time Frame

Up to day 120

Title

Satisfaction with levonorgestrel-releasing intrauterine system

Time Frame

Up to day 120

Title

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

Time Frame

During the 90-day treatment period

Title

Number of bleeding-only days

Time Frame

During the 90-day treatment period

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

København NV

ZIP/Postal Code

DK-2400

Country

Denmark

City

Odense C

ZIP/Postal Code

DK-5000

Country

Denmark

City

Skive

ZIP/Postal Code

DK-7800

Country

Denmark

City

Søborg

ZIP/Postal Code

DK-2860

Country

Denmark

City

Ålborg

ZIP/Postal Code

DK-9000

Country

Denmark

City

Århus C

ZIP/Postal Code

DK-8000

Country

Denmark

City

Mallow

State/Province

Cork

Country

Ireland

City

Blackrock

State/Province

Dublin

Country

Ireland

City

Cork

Country

Ireland

City

Elverum

ZIP/Postal Code

2403

Country

Norway

City

Haugesund

ZIP/Postal Code

5507

Country

Norway

City

Trondheim

ZIP/Postal Code

7012

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

23635728

Citation

Sordal T, Inki P, Draeby J, O'Flynn M, Schmelter T. Management of initial bleeding or spotting after levonorgestrel-releasing intrauterine system placement: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):934-941. doi: 10.1097/AOG.0b013e31828c65d8.

Results Reference

derived

Links:

URL

http://www.clinicaltrialsregister.eu

Description

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Learn more about this trial

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

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