NCT03556800Unknown1 期
A Phase I, Randomized, Open-Label, Single Center, Cross-over Study to Investigate the Pharmacokinetics and Safety Following a Single Application of Three Different Doses 0.5 gm (0.5 mg Estradiol), 0.75 gm (0.75 mg Estradiol) and 1.25 gm (1.25 mg Estradiol), a Transdermal Estradiol Cream (VML-0203), in Comparison to a Single Dose of EstroGelTM 1.25 gm (1 Unit/0.75 mg of Estradiol) to Healthy Post-menopausal Women.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To compare the bio-availability of estradiol and estrone.
研究概览
简要总结
This study is a Phase I, Randomized, Open-Label, Single Center, Cross-over Study to Investigate the Pharmacokinetics and Safety following a Single Application of Three Different Doses 0.5 gm (0.5 mg estradiol), 0.75 gm (0.75 mg estradiol) and 1.25 gm (1.25 mg estradiol), a Transdermal Estradiol Cream (VML-0203), in comparison to a single dose of EstroGelTM 1.25 gm (1 unit/0.75 mg of estradiol) to healthy post-menopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy post-menopausal (surgical or natural) female defined as:
- •No menstrual period within the past year before study entry.
- •Serum estradiol levels between 0-20 pg/ml.
- •FSH levels greater than 25.8 mIU/ml.
- •Greater than 45 years of age or if surgical menopausal, > 30 yrs. of age.
- •Have a body mass index (BMI) between 18 and 30 kg/m
- •Have had a normal PAP smear test result in line with the following guidelines:
- •aged 30 to 49 - within the last 3 years
- •aged 50 to 65 - within the last 5 years
排除标准
- •Is pregnant (urine pregnancy test at screening) or lactating.
- •Has evidence of drug or alcohol abuse.
- •Have used hormonal replacement or vaginal hormonal therapy within the past three months before study entry.
- •Have used estrogen pellet therapy or progestin injectable drug therapy within the past three months before study entry.
- •Has contraindications to HRT use, including: unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events.
- •Any subjects with an obvious presence of skin conditions, excessive hair at the application sites (no shaving), scar tissue, tattoo, or coloration that would interfere with application of IMP, skin assessment, or reactions to drug.
- •Presence of open sores at the application sites.
- •Any subjects with a history of significant skin disorder.
研究组 & 干预措施
0.5 gm of EstroCream (VML-0203)
Experimental
干预措施: Estrogel (Drug)
0.75 gm of EstroCream (VML-0203)
Experimental
干预措施: Estrogel (Drug)
1.25 gm of EstroCream (VML-0203)
Experimental
干预措施: Estrogel (Drug)
1.25 EstroGel
Active Comparator
干预措施: Estrogel (Drug)
结局指标
主要结局
To compare the bio-availability of estradiol and estrone.
时间窗: 4 weeks
Blood samples will be analysed.
次要结局
- To provide general safety information for VML-0203.(4 weeks)
研究者
研究点 (1)
Loading locations...
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