Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Evaluate the histopathological effects on endometrium after each treatment
研究概览
简要总结
To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •post menopause women
- •normal oncotic cytology and mammogram
- •any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm
排除标准
- •vaginal bleeding
- •hormonal replacement on the past three months
- •renal or hepatic desease
- •past venous thromboembolism; ulcerated prolapse
研究组 & 干预措施
Vaginal Moisturizer Cream
use of 1 gram per day
干预措施: Estriol (Drug)
Conjugated Estrogen Group
use of 1 gram per day
干预措施: Promestriene (Drug)
Conjugated Estrogen Group
use of 1 gram per day
干预措施: Estriol (Drug)
Conjugated Estrogen Group
use of 1 gram per day
干预措施: Vaginal Moisturizer - Cream (Drug)
Promestriene Group
use of 1 gram per day
干预措施: Conjugated Estrogen (Drug)
Promestriene Group
use of 1 gram per day
干预措施: Estriol (Drug)
Promestriene Group
use of 1 gram per day
干预措施: Vaginal Moisturizer - Cream (Drug)
Estriol Group
use of 1 gram per day
干预措施: Conjugated Estrogen (Drug)
Estriol Group
use of 1 gram per day
干预措施: Promestriene (Drug)
Estriol Group
use of 1 gram per day
干预措施: Vaginal Moisturizer - Cream (Drug)
Vaginal Moisturizer Cream
use of 1 gram per day
干预措施: Conjugated Estrogen (Drug)
Vaginal Moisturizer Cream
use of 1 gram per day
干预措施: Promestriene (Drug)
结局指标
主要结局
Evaluate the histopathological effects on endometrium after each treatment
时间窗: 48 days
Compare the histopathological results after treatment on each group and among each other
Compare the endometrial thickness measured by ultrassound after each treatment
时间窗: 48 days
Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other
次要结局
- Evaluate the changes of maturation index (Meisels Index) after each treatement(48 days)
- Evaluate the changes on climacteric complaints after each treatment(48 days)
研究者
Elisa Chicareli Pinhat
Doctor
Universidade Federal do Paraná