NCT00247169已完成2 期
Vaginal Progesterone in the Treatment of Cervical Dysplasia Grade I and II: A Phase II Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate whether or not a treatment with vaginal progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25 for 6 months increases regression rates of CIN I and II.
研究概览
简要总结
The investigators want to test whether treatment with a natural progesterone intravaginally increases the cure rate of cervical intraepithelial neoplasia grade I and II.
详细描述
Background:
- The development of cervical intraepithelial neoplasia (CIN) was linked to a decreased local immune response as evidenced by a decrease of Langerhans' cell (LC) count in the cervical epithelium. Preliminary studies show that vaginally administered progesterone locally increases the number of LCs.
- There is no accepted treatment strategy of low grade CIN, i.e., CIN I and II, than await spontaneous regression.
Thus, vaginal progesterone is expected to increase the regression rate of cervical dysplasia grade I and II.
Outcome parameters:
Primary outcome parameters:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological evidence of CIN I and II
- •Transformation zone and lesion margins fully visible
- •Compliant subject
- •Safe contraception
- •Negative pregnancy test
排除标准
- •Lesion related
- •CIN III, (micro)-Invasive Cancer
- •Endocervical lesion, upper margin of lesion not visible on colposcopy
- •Non-compliance of patient
- •Drug related
- •Hypersensitivity to progesterone or any component of the formulation
- •Thrombophlebitis
- •Undiagnosed vaginal bleeding
- •Carcinoma of the breast
- •Cerebral apoplexy
- •Severe liver dysfunction
- •Renal dysfunction
- •HIV infection
- •Hepatitis B or C
- •Concurrent use of anticoagulants
- •Uncontrolled hypertension (> 160/90 mmHg)
- •Breast cancer in personal history
- •Concurrent hormonal therapy including OC
- •Clinical laboratory related
- •Hemoglobin < 11 g/dl
- •Leukocytes < 4,0 x 109/L
- •Platelet count < 100 x 109/L
- •Serum bilirubin > 2 x above upper cut-off value
- •Serum GOT > 2 x above upper cut-off value
- •Serum GPT > 2 x above upper cut-off value
- •Serum alkaline phosphatase > 2 x above upper cut-off value
- •Serum creatinine > 2 x above cut-off value
结局指标
主要结局
To evaluate whether or not a treatment with vaginal progesterone 400mg 1x daily for 10 days/month from menstrual cycle day 16-25 for 6 months increases regression rates of CIN I and II.
时间窗: 6 months
次要结局
- Change of immunohistochemically detected expression of Langerhans Cells in CIN(6 months)
研究者
LHefler
Assoc Professor
Medical University of Vienna
研究点 (1)
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