Uterine Hemorrhage
Conditions
Keywords
Uterine Hemorrhage, Contraception, Contraceptive Methods, Intrauterine devices, Mirena
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.
Interventions
DRUGTranexamic acid
500 mg 3 times daily per oral during bleeding/spotting episodes
DRUGMefenamic acid
500 mg 3 times daily per oral during bleeding/spotting episodes
DRUGPlacebo
3 times daily per oral during bleeding/spotting episodes
In vitro release rate 20 microgram/24 hours. Intrauterine system
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable will be the cumulative number of bleeding / spotting days | During 90 day double-blind treatment period |
Secondary
| Measure | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Number of spotting-only days | During the 90-day treatment period |
Countries
Denmark, Ireland, Norway
Outcome results
None listed