Randomized, Controlled, Open-label, Parallel, Clinical Trial to Assess Pharmacokinetics and Endometrial Effect of an Injectable Formulation of Progesterone Microspheres in Doses of 50 mg, 100 mg, 200 mg and 300 mg, in Postmenopausal Women.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Endometrial dating through histopathologic criteria.
研究概览
简要总结
Phase: I pharmacokinetic - pharmacodynamic (PK-PD) study. Main objective: To establish the minimum effective dose of progesterone microspheres suspension, which administered by weekly intramuscular injection, will be able to induce transformation from a proliferative endometrium to a secretory endometrium.
Study design: Randomized, controlled, open-label, parallel, dose-response clinical trial.
Sites: 1 Subjects: 48 postmenopausal women.
详细描述
Sites: 1 Phase: 1 Main objective:To establish the minimum effective dose of progesterone microspheres suspension, which administered by weekly intramuscular injection, will be able to induce transformation from a proliferative endometrium to a secretory endometrium.
Secondary objectives:
- To determine and compare the steady-state pharmacokinetic profile of investigational products.
- To evaluate safety profile of investigational products in the study subjects.
- To evaluate local tolerability of investigational products in the study subjects.
Study design:Randomized, controlled, open-label, parallel, dose-response clinical trial.
Investigational products:
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
- 是
入选标准
- •45 to 60 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
- •Severe gastrointestinal disease
- •History of serious neurologic disease
- •Reduced mobility
- •Previous or concomitant hormonal therapy
- •Previous or concomitant therapy with inhibitors or inductors of cytochrome
研究组 & 干预措施
50 mg
Progesterone microspheres injectable suspension 50 mg
干预措施: Progesterone (Drug)
100 mg
Progesterone microspheres injectable suspension 100 mg
干预措施: Progesterone (Drug)
200 mg
Progesterone microspheres injectable suspension 200 mg
干预措施: Progesterone (Drug)
300 mg
Progesterone microspheres injectable suspension 300 mg
干预措施: Progesterone (Drug)
结局指标
主要结局
Endometrial dating through histopathologic criteria.
时间窗: 10 days
Endometrial dating according Noyes criteria as a measure of efficacy. At the moment of the biopsy, study subjects would have received 25 days of estradiol valerate pretreatment and 10 days of progesterone (investigational product); thus simulating the 25th day of a menstrual cycle. Efficacy will be measured as number of biopsies that have histological date according to cronological date.
次要结局
- Pharmacokinetics(0 -60 days.)
- Adverse events(0 - 65 days)
研究者
Roberto Bernardo Escudero
Principal Investigator
Productos Científicos S. A. de C. V.