Treatment of Patients With Endometriosis Recurrence With Aromatase Inhibitor (Anastrazole) Plus GnRH-agonist (Luprolide).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- disease free time
研究概览
简要总结
The aromatase inhibitor (anastrazole) plus long acting GnRH agonist leuprolide acetate will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.
详细描述
Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing recurrence after surgery at least in 20-50% after 5 years of follow-up. Aromatase inhibitor plus GnRH analog may be more effective than GnRH agonist alone in the treatment of endometriosis recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women affected by endometriosis showing recurrence of pain symptoms, previous surgery for endometriosis
排除标准
- •presence of other systemic diseases
研究组 & 干预措施
anastrazole
women with endometriosis recurrence will be treated with Leuprolide acetate 11,25mg plus anastrazole 1mg/day for three months
干预措施: anastrazole (Drug)
GnRH analog alone
women with endometriosis recurrence will be treated with leuprolide acetate 11.25mg
干预措施: GnRH analog alone (Drug)
结局指标
主要结局
disease free time
时间窗: 24 months
time without pain symptoms due to the disease recurrence
次要结局
- time of pain disappearance(24 months)
研究者
Fabio Scarpellini
PRINCIPAL INVESTIGATOR
Centre for Endocrinology and Reproductive Medicine, Italy