Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.
研究概览
简要总结
The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.
详细描述
Estrogen Replacement Therapy must be opposed by progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer, in women with an intact uterus.
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
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are candidates for Hormone Replacement Therapy due to menopausal symptoms.
- •Women with an intact uterus.
- •No menses within the 12 months preceding screening visit and /or FSH >30 IU/L.
- •Endometrial thickness ≤ 5 mm.
排除标准
- •Submucosal fibroid/s that applying pressure and affecting endometrial thickness
- •Other medication that could affect estrogenic state.
研究组 & 干预措施
Progesterone vaginal tablet
Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.
干预措施: progesterone (Drug)
Activella
Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
干预措施: activella (Drug)
结局指标
主要结局
Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.
时间窗: 1 year
次要结局
- Comparison of the proportion of bleeding pattern between the two groups.(1 year)
- To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire.(1 year)