LNG-IUS or Norethisterone Acetate for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.
研究概览
简要总结
The purpose of this study is to compare the efficacy of the Levonorgestrel releasing Intrauterine System (Mirena) and Norethisterone Acetate for treatment of non-atypical endometrial hyperplasia in perimenopausal women.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed simple or complex endometrial hyperplasia without atypia
排除标准
- •Endometrial hyperplasia with atypia
- •Other pathology e.g. patients with fibroids of any size, genital infection, adnexal abnormality.
研究组 & 干预措施
LNG-IUS
Release rate of 20µg Levonorgestrel(Mirena, Bayer Schering Pharma Oy, Finland) per day with one year follow up.
干预措施: LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland (Drug)
Norethisterone Acetate
Norethisterone Acetate tablets at a dose of 5 mg three times daily (15mg/day) for 3 weeks over three months.With persistence of endometrial hyperplasia, the treatment is repeated for another 3 months
干预措施: Norethisterone Acetate tablets (Drug)
结局指标
主要结局
Change in endometrial histopathology pattern from endometrial hyperplasia into regression status.
时间窗: At 3 and 6 months
次要结局
- Time to achieve complete regression(During the follow up period at 3,6,12 months after treatment)
研究者
Hatem AbuHashim
Associate Professor of Obstetrics & Gynecology.
Mansoura University