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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020922-16 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028) | Experimental | Subjects with successful MIRENA insertion will receive treatments with tranexamic acid |
|
| mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028) | Experimental | Subjects with successful MIRENA insertion will receive treatments with mefenamic acid |
|
| placebo + Mirena (Levonorgestrel IUS, BAY86-5028) | Placebo Comparator | Subjects with successful MIRENA insertion will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | 500 mg 3 times daily per oral during bleeding/spotting episodes |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable will be the cumulative number of bleeding / spotting days | During 90 day double-blind treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg | DK-9000 | Denmark | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23635728 | Derived | 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. |
| Label | URL |
|---|---|
| Click here and search for information of Bayer products for Europe | View source |
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| Mefenamic acid | Drug | 500 mg 3 times daily per oral during bleeding/spotting episodes |
|
| Placebo | Drug | 3 times daily per oral during bleeding/spotting episodes |
|
| Mirena (Levonorgestrel IUS, BAY86-5028) | Drug | In vitro release rate 20 microgram/24 hours. Intrauterine system |
|
| 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 |
| 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 |
| Århus C |
| DK-8000 |
| Denmark |
| København NV | DK-2400 | Denmark |
| Odense C | DK-5000 | Denmark |
| Skive | DK-7800 | Denmark |
| Søborg | DK-2860 | Denmark |
| Mallow | Cork | Ireland |
| Blackrock | Dublin | Ireland |
| Cork | Ireland |
| Elverum | 2403 | Norway |
| Haugesund | 5507 | Norway |
| Trondheim | 7012 | Norway |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D008528 | Mefenamic Acid |
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D054361 | Fenamates |
| D062367 | ortho-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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