Trial Condition(s):
Uterine Hemorrhage
Management of initial bleeding/spotting associated with the levonorgestrel-releasing intrauterine system (MIRENA)
Bayer Identifier:
15105
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Specialistlægesellskabet John Dræby ApS Odense C, Denmark, DK-5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Speciallæge Anette Peen Århus C, Denmark, DK-8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Mary Short Blackrock, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Practrice Mallow, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Langford Hall Medical Centre Cork, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Speciallæge Lise Helmsøe-Zinck Søborg, Denmark, DK-2860 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinik for kvindesygdomme & graviditet Skive, Denmark, DK-7800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Speciallæge Morten Ring Ålborg, Denmark, DK-9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Speciallæge Claus Christoffersen København NV, Denmark, DK-2400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medicus AS Trondheim, Norway, 7012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kvinnelegen i Hedmark Elverum, Norway, 2403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Haugesund Gyn Klinikk AS Haugesund, Norway, 5507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Single Group Assignment
Trial Arms:
3
Primary Outcome
- The primary efficacy variable will be the cumulative number of bleeding / spotting daysTimeframe: During 90 day double-blind treatment period
Secondary Outcome
- To describe and compare the bleeding patterns observed in women during treatment periodTimeframe: 90 day treatment period
- To describe and compare the bleeding patterns observed in women during follow-up periodTimeframe: During the 30 day follow-up period
- Satisfaction with oral blinded study drug treatment for bleeding / spottingTimeframe: 90 day treatment period
- Occurrence of dysmenorrheaTimeframe: During 120 day study period
- Continuation rate with study drugTimeframe: During the 90 day treatment period
- Continuation rate with MirenaTimeframe: During 120 day study period
- Adverse Events CollectionTimeframe: Until day 120
- Number of spotting-only daysTimeframe: During the 90-day treatment period
- Number of bleeding / spotting episodesTimeframe: During the 90-day treatment period
- Length of bleeding / spotting episodesTimeframe: During the 90-day treatment period
- Number of bleeding days with heavy intensityTimeframe: 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 periodTimeframe: Up to day 120
- Satisfaction with levonorgestrel-releasing intrauterine systemTimeframe: Up to day 120
- Number of days of pain medication for dysmenorrhea during the 90 day treatment periodTimeframe: During the 90-day treatment period
- Number of bleeding-only daysTimeframe: During the 90-day treatment period
Additional Information
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