Multiple-dose Pharmacokinetic Study of Two Aqueous Suspensions of Estradiol and Progesterone Microspheres (1 mg/20 mg & 0.5 mg/15 mg) for Intramuscular Administration, in Postmenopausal Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
Phase I pharmacokinetic study
Main objective:
To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration
Study design:
Randomized, controlled, open-label, parallel, pharmacokinetic study
Sites: 1
Subjects: 30 postmenopausal women
详细描述
Sites: 1
Phase: 1
Main objective:
To determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration.
Secondary objectives:
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •45 to 65 years old
- •Able to read and write
- •Postmenopausal
- •Body Mass Index equal or below 34.99 kg/m2
- •Normal uterus
- •Time availability
排除标准
- •Hypersensitivity to progesterone or related compounds
- •Hypersensitivity to estrogens
- •Hysterectomy
- •History or present hormone-dependent tumor
- •History or present uterine cervix dysplasia
- •Abnormal and clinically-significant laboratory test results
- •Family history of breast cancer
- •History of thromboembolic disease
- •Non-controlled hypertension
- •History of stroke
- •History of cardiac valve surgery
- •Renal failure
- •Hepatic failure
- •Non-controlled diabetes
- •History of serious neurologic disease
- •Reduced mobility
- •Previous or concomitant hormone therapy
- •Previous or concomitant therapy with inhibitors or inductors of cytochrome
研究组 & 干预措施
Estradiol 0.5 mg/Progesterone 15 mg microspheres
Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension
干预措施: Estradiol + Progesterone (Drug)
Estradiol 1 mg/Progesterone 20 mg microspheres
Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension
干预措施: Estradiol + Progesterone (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 0 - 60 Days
Estrogen and progesterone plasma concentrations and pharmacokinetic parameters.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(0 - 60 days)
研究者
Roberto Bernardo Escudero
Principal Investigator
Productos Científicos S. A. de C. V.