Management of bleeding/spotting in women using the levonorgestrel-releasing intrauterine system (Mirena) for contraception. MedDRA version: 12.1 Level: LLT Classification code 10046883 Term: Vaginal bleeding
Conditions
Interventions
Trade Name: Cyklokapron
Product Name: Tranexamic acid
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name:
Sponsors
Bayer Healthcare AG
Eligibility
Sex/Gender
All
Inclusion 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 (length of cycle 21 - 35 days, i.e. endogenous cyclicity without hormonal contraceptive use) -Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 12 months) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Pregnancy or lactation -Immediate switch from a previous MIRENA to a new MIRENA (subject is not eligible before she has had at least 2 complete menstrual cycles after removal of a previous MIRENA). -Vaginal delivery, Cesarean delivery, or abortion within 6 weeks prior to the screening visit (Visit 1). -Infected abortion or postpartum endometritis within 3 months prior to the screening visit (Visit 1) -Predominant indication for MIRENA use is idiopathic menorrhagia/HMB or endometrial protection during estrogen replacement therapy -Climacteric symptoms prior to the screening visit (Visit 1) -Known or suspected congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity -Current or recurrent pelvic inflammatory disease -Known or suspected genital or other malignancy or untreated cervical dysplasia -Undiagnosed abnormal genital bleeding -Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled -Conditions associated with increased susceptibility to pelvic infections -Active liver disease or liver tumor -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 -Uncontrolled hypertension -Current or history of severe arterial disease such as stroke or myocardial infarction -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 -Disturbances of color vision -Inflammatory bowel disease -History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy -Active or history of peptic ulcer/hemorrhage -Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational medicinal products (e.g. severe renal, liver or heart failure) -Hypersensitivity to any ingredient of the investigational medicinal products (TXA, MFA, and placebo) or the non-investigational medicinal product (MIRENA) -Previous hypersensitivity reaction (e.g. asthma, bronchospasm, rhinitis, angioedema, or urticaria) to aspirin, ibuprofen, or other NSAIDs -Daily or frequent use of NSAIDs for any condition -Not willing to use non-NSAID medication as pain medication during the double-blind treatment period -Other medication known to affect vaginal bleeding pattern (including, but not limited to, TXA, daily use of NSAIDs, gonadotropin-releasing hormone (GnRH) analogues, danazol, progestins, estrogens, anticoagulants) is prohibited during the whole study -Long-acting preparations (e.g. DMPA, monthly contraceptive injection, contraceptive implant) within 3 months before start of treatment -The use of oral, vaginal, injectable, or transdermal hormonal contraception, Copper IUDs, and implants is prohibited during the whole study -Abuse of alcohol, drugs, or medicine (e.g. laxatives) -Simultaneous participation in another clinical study. Participation in another clinical study prior to study entry that might have an impact on the study objectives, at the discretion of the investigator. -Major surgery scheduled for the study period -Any dis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if tranexamic acid and/or mefenamic acid are superior to placebo in the management of bleeding/spotting during the first 90 days of levonorgestrel-releasing intrauterine system use.;Secondary Objective: -To compare the number of bleeding/spotting (B/S) days during the 30-day follow-up period in the 3 treatment groups, and the change in the number of B/S days between Day 60 and Day 90 of levonorgestrel-releasing intrauterine system use and the 30-day follow-up period in the 3 treatment groups. -To investigate subject satisfaction and continuation rate with tranexamic acid, mefenamic acid, or placebo treatment for B/S. -To investigate subject satisfaction and continuation rate with the levonorgestrel-releasing intrauterine system in women treated with tranexamic acid, mefenamic acid, or placebo. -To investigate the safety of tranexamic acid and mefenamic acid in the management of B/s during the first 90 days of levonorgestrel-releasing intrauterine system use. -To investigate the occurrence of dysmenorrhea before and after levonorgestrel-releasing intrauterine system insertion and the effect blinded study drug treatment for B/S on the need of pain medication for dysmenorrhea.;Primary end point(s): The primary efficacy variable will be the cumulative number of B/S days during the 90-day double-blind treatment period. Secondary efficacy variables: -Number of bleeding-only days -Number of spotting-only days -Number of B/S episodes -Length of B/S episodes -Number of bleeding days with heavy intensity -Number of days and number and length of episodes of oral blinded study drug treatment during the 90-day treatment period -Number of B/S days, number of bleeding-only days, number of spotting-only days, number of B/S episodes, and number of bleeding days with heavy intensity, during the 30-day follow-up period -Change in the number of B/S days between Day 60 and Day 90 of MIRENA use (last 30 days on oral blinded study drug) and the 30-day foll | — |
Countries
Denmark, Ireland
Outcome results
None listed