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

PHASE4CompletedINTERVENTIONAL
Enrollment

187

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Uterine Hemorrhage
Interventions
DRUG

Tranexamic acid

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

DRUG

Mefenamic acid

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

DRUG

Placebo

3 times daily per oral during bleeding/spotting episodes

DRUG

Mirena (Levonorgestrel IUS, BAY86-5028)

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

Trial Locations (12)

2403

Elverum

5507

Haugesund

7012

Trondheim

DK-9000

Aalborg

DK-8000

Århus C

DK-2400

København NV

DK-5000

Odense C

DK-7800

Skive

DK-2860

Søborg

Unknown

Mallow

Blackrock

Cork

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY