Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy: Effects on Blood Pressure, Insulin and C-reactive Protein and in Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 3
- 主要终点
- Blood Pressure variation
研究概览
简要总结
The study aims to asses the effects of micronized (MIC) and nanoparticulate (NANO) transdermal hormone therapy (THT) on blood pressure, ultra-sensitive C-reactive protein (CRP), and cardiovascular risk factors in postmenopausal women.
详细描述
In this open label study, 27 postmenopausal women, with no clinical evidence of cardiovascular disease, were randomly divided in two groups.
During 12 weeks,
15 patients received on the left forearm micronized (MIC) THT (micronized 17β-estradiol 2.5 mg/day + progesterone 100 mg/day).
and
14 patients received a nanoparticulate (NANO) THT (nanoparticulate 17β-estradiol 2.5 mg/day + progesterone 100mg/day).
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
- 42 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A body mass index between 18 and 27 kg/m2;
- •Sex live complaints;
- •No evidence of cardiovascular disease;
- •General good health based on history and physical examination.
排除标准
- •A past history of neurological disorder;
- •Had received pharmacotherapy for cardiovascular disease before screening
- •Taking medication known to interfere with steroids;
- •Recent psychiatric or systemic illness;
- •Uncontrolled hypertension (blood pressure>160/95mmHg),
- •Unstable cardiovascular disease;
- •Genital bleeding;
- •Use of psychoactive medications,
- •Alcohol excess consumption or any other drug abuse;
研究组 & 干预措施
NANOPARTICULATE estradiol+ progesterone
The Blood samples are collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal nanostructured estradiol and progesterone is prescribed.
The patients are evaluated 3 months after THRT treatment protocol. All the patients were instructed about how to use the pump for transdermal application, the first application is performed in the presence of an experienced physician, in order to guarantee standardization and correct use of the THRT. Compliance was defined as completing seventy percent or more of the transdermal applications.
干预措施: Nanoparticulate estradiol + progesterone (Drug)
MICRONIZED estradiol+ progesterone
The Blood samples are collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal micronized estradiol and progesterone is prescribed.
The patients are evaluated 3 months after THRT treatment protocol. All the patients were instructed about how to use the pump for transdermal application, the first application is performed in the presence of an experienced physician, in order to guarantee standardization and correct use of the THRT. Compliance was defined as completing seventy percent or more of the transdermal applications.
干预措施: Micronized estradiol + progesterone (Drug)
结局指标
主要结局
Blood Pressure variation
时间窗: 12 weeks
次要结局
- C-reactive protein levels after treatment(12 weeks)
研究者
MARCO BOTELHO
PhD
University Potiguar