Effect of Genistein on Endometrial Hyperplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Recovery from endometrial hyperplasia
研究概览
简要总结
The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non atypical endometrial hyperplasia", in premenopausal women.
详细描述
Although isoflavones alone (example: Genistein) have weak estrogenic effects on endometrial stromal and glandular cells, it was demonstrated, in several research efforts, that in the presence of E2 they act as antiestrogens.
Considered that endometrial hyperplasia is due to strong and extended estrogenic stimulation, not offset by a proportionate amount of progesterone, we suppose that genistein could be therapeutic in these cases inducing a decrease of the hyperplasia and a change from the proliferative to a secretory phase of the endometrium.
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
- 44 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women
- •Age > = 44 years
- •Dysfunctional uterine bleeding
- •No treatment with other hormonal drugs (estrogen, progesterone)
- •No local or general pathology negatively influenced by administration of genistein or progesterone
- •No intrauterine pathologies (polyps, myomas)
- •A "non atypical endometrial hyperplasia", confirmed by hysteroscopy with biopsy and histological examination
排除标准
- •All the other conditions
研究组 & 干预措施
Genistein
Genistein 54 mg/day
干预措施: Genivis (Dietary Supplement)
Norethisterone Acetate
Norethisterone Acetate 10mg/day
干预措施: Norethisterone Acetate (Drug)
Placebo
Placebo tablets, daily
干预措施: placebo (Other)
结局指标
主要结局
Recovery from endometrial hyperplasia
时间窗: 3-6 months
次要结局
- Differential expression of ER-a and ER-b in endometrial specimens(6 months)