NCT01635452Unknown不适用
A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids
适应症
试验速览
- 阶段
- 不适用
- 发起方
- PregLem SA
- 入组人数
- 1,500
- 试验地点
- 61
- 主要终点
- Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation.
研究概览
简要总结
This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA.
The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal adult women with a diagnosis of moderate or severe symptoms of uterine fibroids who are initiating treatment with ESMYA.
排除标准
- •Patient is pregnant or plans to become pregnant in the next 3 months,
- •Patient is breastfeeding,
- •Patient has genital bleeding of unknown etiology or not due to uterine fibroids,
- •Patient has been diagnosed with uterine, cervical, ovarian or breast cancer,
- •Patient is using an investigational drug/therapy or has discontinued the use of an investigational drug/therapy within 30 days prior to study enrollment,
- •Patient has hypersensitivity to the active substance of ESMYA or to one of its excipients
结局指标
主要结局
Occurrence of SAEs, adverse events (AEs) considered to be related to ESMYA or AEs leading to ESMYA treatment discontinuation.
时间窗: Patients will be followed from baseline up to 15 months
次要结局
未报告次要终点
研究者
研究点 (61)
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