Vaginal Micronized Progesterone or Levonorgestrel-releasing Intrauterine System (LNG-IUS) for Treatment of Non-atypical Endometrial Hyperplasia: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Regression and remission rate of endometrial hyperplasia
研究概览
简要总结
The purpose of this study is to compare the efficacy of the vaginal micronized progesterone and Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia in premenopausal women.
详细描述
Vaginal use of micronized progesterone in the treatment of endometrial hyperplasia can result in better than oral administration, as it will remain away from the first pass effect, and depending on the local application. In this study, we aimed to compare this local treatment with Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal Patients
- •Patients with histologically confirmed endometrial hyperplasia without atypia
排除标准
- •Endometrial hyperplasia with atypia
- •Endometrial Carcinoma
- •Suspected pathology on Physical/Ultrasonographic Examination e.g. fibroids, adnexal abnormality
研究组 & 干预措施
Vaginal Micronized Progesterone
Micronized progesterone tablets at a dose of 200 mg once a day vaginally, for 12 days (Between 14'th-25'th days of the menstrual cycle) over three months. With persistence of endometrial hyperplasia, the treatment is repeated for another 3 months
干预措施: Vaginal Micronized Progesterone (Drug)
LNG-IUS
Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day with one year follow up.
干预措施: Levonorgestrel-Intrauterine System (Device)
结局指标
主要结局
Regression and remission rate of endometrial hyperplasia
时间窗: 3 month
Endometrial sampling will be performed for 3'th month with Carmen canula. Pathological specimens will be reported by the specialist pathologist in accordance with the World Health Organisation (WHO) endometrial hyperplasia classification.
次要结局
- Mean Reduction From Baseline in Menstrual Blood Loss(6 month)
- Number of Participants with adverse events associated with medication and device(6 month)
研究者
Şener Gezer
Principal Investigator
Kocaeli University