Efficacy of Subcutaneous Progesterone in Premenopausal Woman With Endometrial Polyp: a Multicentric Randomized Control Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Polyps regression rate
研究概览
简要总结
This prospective randomized study will compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle
详细描述
In premenopause, 25% of endometrial polyps regresses spontaneously in 1 year. According to guidelines, given that most premenopausal polyps are not malignant, there is an option for expectant approach with no surgical intervention. Studies on the efficacy of medical treatments for endometrial polyps are also recommended by gynaecologic societies, with the aim of finding cost-saving not invasive strategies to manage this common pathology. Up to now, nobody has investigated the effect of progestin administration on polyps, but molecular and clinical data suggest that the antiestrogenic effect of this hormone can be exploited to increase and speed-up their regression rate. Our preliminary results on the effect of three months of progesterone demonstrated a regression rate of 47,5% in women treated vs 12,5% in those don't receiving treatment.
Accordingly, in this prospective randomized study we aim to compare the regression rates of women managed with watch-and-wait approach and of those treated with 3 cycles of luteal 25mg subcutaneous progesterone from 18 to 25 days of menstrual cycle
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ultrasound diagnosis of endometrial polyps no more than 30 days before the enrollment
- •signed informed consent
排除标准
- •estrogenic and\or progestinic therapy two months before the enrollment
- •tamoxifen therapy
- •pelvic inflammatory disease
- •gynaecologic neoplasia
- •previous chemotherapy and radiotherapy
- •autoimmune diseases, chronic disease, metabolic, and endocrine (hyperandrogenism, hyperprolactinemia, diabetes mellitus and thyroid disease)
- •menopause
- •Hypogonadotropic hypogonadism
- •drugs causing menstrual irregularities
研究组 & 干预措施
Progesterone patients
Treatment consists of 7 days of 25 mg subcutaneous progesterone administered from 18° to 25° day of the menstrual cycle and repeated for 3 cycles
干预措施: subcutaneous progesterone (Drug)
结局指标
主要结局
Polyps regression rate
时间窗: three months after the starting of treatment or of watch-wait approach
US evidence of normal endometrial line without evidence of polyps
次要结局
- Progesterone effects on menstrual bleeding assessed with PBAC (Pictorial blood loss assesment chart) score(three months after the starting of treatment)
- Polyps dimensions(three months after the starting of treatment or of watch-wait approach)
- Correlation between polyps dimension and regression(three months after the starting of treatment or of watch-wait approach)
- Side effects(three months after the starting of treatment)
研究者
Roberta Venturella
Principal investigator
University Magna Graecia