A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR)
研究概览
简要总结
This prospective study collected safety information from more than 600 participants treated with Pergoveris®.
During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical history, Pergoveris® indication, prior infertility medication, Pergoveris® treatment status, concomitant drugs, all adverse events (regardless of the causal relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) were collected for study purposes.The post marketing surveillance was based on all cases treated with Pergoveris®.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants, who were eligible for Pergoveris® treatment according to the indication in the national label of Pergoveris®. The national label approved by Korea Food & Drug Administration is "Pergoveris® in association with a follicle stimulating hormone(FSH) preparation was recommended for the stimulation of follicular development in women with severe Luteinizing Hormone (LH) and FSH deficiency. In clinical trials these participants were defined by an endogenous serum LH level less than (<)1.2 International units per liter IU/L"
排除标准
- •According to national label
结局指标
主要结局
Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR)
时间窗: 2463 days
Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse events included both Serious AEs and non-serious AEs. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse Drug Reactions (ADR) was defined as an adverse event for which a causal relationship between the product and the occurrence was suspected, that was judged possible or probable by the reporting physician.
次要结局
- Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography(2463 days)
- Number of Participants With Clinical Pregnancy as Per Safety Analysis Set(2463 days)
- Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set(2463 days)