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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 187
- 主要终点
- The primary efficacy variable will be the cumulative number of bleeding / spotting days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)
Subjects with successful MIRENA insertion will receive treatments with tranexamic acid
干预措施: Tranexamic acid (Drug)
tranexamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)
Subjects with successful MIRENA insertion will receive treatments with tranexamic acid
干预措施: Mirena (Levonorgestrel IUS, BAY86-5028) (Drug)
mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)
Subjects with successful MIRENA insertion will receive treatments with mefenamic acid
干预措施: Mefenamic acid (Drug)
mefenamic acid + Mirena (Levonorgestrel IUS, BAY86-5028)
Subjects with successful MIRENA insertion will receive treatments with mefenamic acid
干预措施: Mirena (Levonorgestrel IUS, BAY86-5028) (Drug)
placebo + Mirena (Levonorgestrel IUS, BAY86-5028)
Subjects with successful MIRENA insertion will receive placebo
干预措施: Placebo (Drug)
placebo + Mirena (Levonorgestrel IUS, BAY86-5028)
Subjects with successful MIRENA insertion will receive placebo
干预措施: Mirena (Levonorgestrel IUS, BAY86-5028) (Drug)
结局指标
主要结局
The primary efficacy variable will be the cumulative number of bleeding / spotting days
时间窗: During 90 day double-blind treatment period
次要结局
- 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)
- 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)