NCT00931827已完成不适用
Acceptability of Long-term Progestin-only Contraception in Europe
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 436
- 主要终点
- Continuation rate
研究概览
简要总结
The study examines the use of Mirena or Implanon for long-term contraception in women. The duration of therapy use is the key focus of the study. Also, any reasons for discontinuation and the safety profile will be examined. In addition, patients are asked to fill out a short questionnaire about their menstrual bleeding before and during therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20-35 in good general health requesting contraception
- •Women who have used short-acting hormonal contraception (combined or progestogen-only pills, vaginal ring or contraceptive patch) for at least 3 cycles immediately before entering the study and opting to change to either Mirena or Implanon for contraception
- •Women who have given a written informed consent to participate in the study (if applicable)
排除标准
- •The contraindications and warnings of the respective Summary of Product Characteristics (Mirena or Implanon) must be followed. The decision to start Mirena or Implanon has to be made clearly before the decision to include patients in the study
- •Patients who are breast-feeding at time of inclusion for the study will also be excluded since breast-feeding affects the bleeding pattern
研究组 & 干预措施
Group 1
干预措施: Levonorgestrel IUS (Mirena, BAY86-5028) (Drug)
Group 2
干预措施: Implanon (Etonogestrel) (Drug)
结局指标
主要结局
Continuation rate
时间窗: At 24 months
次要结局
- The return to fertility of women discontinuing the method for wish for pregnancy(12 months after discontinuation)
- Continuation rate(At 12 months)
- Bleeding intensity, dysmenorrhea, and user satisfaction (questionnaires completed by patient)(Initial and after 3, 6, 12 and 24 months)
- Cumulative discontinuation rate for unintended pregnancy, bleeding problems, other medical reasons, for non-medical reasons(At 24 months)
- Incidence of Adverse Events, Serious Adverse Events(During 24 months)
研究者
相似试验
已完成
不适用
Study Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct TechniqueContraceptionNCT02595125Centre Hospitalier Universitaire de Saint Etienne60
已完成
4 期
A Study to Compare the Menstrual Bleeding Profile Among Jaydess® and Copper Intrauterine Device (IUD) Users. COLIBRI STUDY (Copper and Levonorgestrel IUD Barcelona Research Initiative).ContraceptionNCT02957292Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau108
进行中（未招募）
4 期
Effects of the Contraceptive Implant in Women With Sickle Cell DiseaseSickle Cell DiseaseNCT05730205University of Pennsylvania22
已完成
4 期
Long-Acting Reversible ContraceptionContraceptionNCT01299116FHI 360916
Unknown
不适用
Effect of Implantable Contraception on Type-2 DM and Metabolic Syndrome in Women With History of Gestational DMMetabolic SyndromeDiabetes MellitusNCT02114476Mahidol University260